Polymer Patient Examination Glove
The Polymer Patient Examination Glove (product code LZA) is a disposable device made of nitrile rubber or synthetic polymers intended to be worn on the hand during medical examinations and procedures to provide a barrier against potentially infectious materials and other contaminants, and may or may not contain a trace amount of residual powder. Regulated under 21 CFR 880.6250 and classified as a Class 1 device, it falls under the General Hospital specialty and is eligible for third-party review. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- LZA
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1159 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Jul 09, 2025 | Substantially Equivalent | Basic Medical Technology Inc. |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Jul 08, 2025 | Substantially Equivalent | Encompass Industries Sdn. Bhd. |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Jul 07, 2025 | Substantially Equivalent | Zibo Shengkun Chemical Industry Co., Ltd |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | Jun 18, 2025 | Substantially Equivalent | O&M Halyard, Inc. |
| K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Jun 17, 2025 | Substantially Equivalent | KL-Kepong Rubber Products SDN. BHD. |
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Jun 06, 2025 | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. |
| K243796 | GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Jun 03, 2025 | Substantially Equivalent | Glove One, LLC |
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | May 22, 2025 | Substantially Equivalent | Basic Medical Technology Inc. |
| K250944 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | Apr 23, 2025 | Substantially Equivalent | GMP Medicare Sdn. Bhd. |
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Apr 01, 2025 | Substantially Equivalent | Careglove Global Sdn. Bhd. |
| K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) | Mar 19, 2025 | Substantially Equivalent | SafeSource Direct LLC |
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mar 18, 2025 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. |
| K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | Feb 18, 2025 | Substantially Equivalent | Basic Medical Technology Inc. |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Feb 06, 2025 | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation |
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Jan 31, 2025 | Substantially Equivalent | Basic Medical Technology Inc. |
| K242936 | Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jan 15, 2025 | Substantially Equivalent | Sunray Medical Products Inc. |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Jan 08, 2025 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Dec 17, 2024 | Substantially Equivalent | O&M Halyard, Inc. |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | Oct 25, 2024 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K242812 | NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) | Oct 12, 2024 | Substantially Equivalent | NB MEDICAL COMPANY LIMITED |
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Sep 27, 2024 | Substantially Equivalent | O&M Halyard, Inc. |
| K241745 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | Sep 11, 2024 | Substantially Equivalent | KSG Medicare Sdn. Bhd. |
| K240545 | GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) | Aug 28, 2024 | Substantially Equivalent | Genabio Diagnostics Inc. |
| K241780 | Cardinal Health Nitrile Exam Gloves | Aug 23, 2024 | Substantially Equivalent | Cardinal Health 200, LLC |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | Aug 06, 2024 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K241970 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) | Aug 02, 2024 | Substantially Equivalent | Kanglongda Vietnam Protection Technology Company Limited |
| K240930 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue | Jul 02, 2024 | Substantially Equivalent | Sri Trang Gloves Thailand (Public Company Limited) |
| K240824 | Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) | Jun 25, 2024 | Substantially Equivalent | Ningxia Qiaoen Medical Technology Co., LTD |
| K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | May 28, 2024 | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. |
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | May 13, 2024 | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited |
| K232319 | Black Pearl Nitrile Examination Glove | Apr 22, 2024 | Substantially Equivalent | UG Global Resources Sdn. Bhd. |
| K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Apr 08, 2024 | Substantially Equivalent | Yue Kang Anhui Medical Products Co., Ltd |
| K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | Apr 04, 2024 | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. |
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Apr 02, 2024 | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. |
| K233990 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Apr 01, 2024 | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd. |
| K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mar 27, 2024 | Substantially Equivalent | Ever Growth (Vietnam) Corporation Limited |
| K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Mar 22, 2024 | Substantially Equivalent | O&M Halyard, Inc. |
| K232654 | Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Mar 20, 2024 | Substantially Equivalent | Nephron Nitrile, LLC. |
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves | Mar 01, 2024 | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd |
| K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Feb 29, 2024 | Substantially Equivalent | Lingshi Hongruida Health Protection Technology Co., Ltd. |
| K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | Feb 26, 2024 | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. |
| K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Feb 13, 2024 | Substantially Equivalent | W.A. Rubbermate Co., Ltd. |
| K240072 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Feb 09, 2024 | Substantially Equivalent | Luliang Hongruida Health Protection Technology Co., Ltd. |
| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Feb 07, 2024 | Substantially Equivalent | ECO Medi Glove Sdn. Bhd |
| K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Jan 26, 2024 | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd. |
| K233970 | Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Jan 16, 2024 | Substantially Equivalent | Nephron Nitrile, LLC. |
| K233520 | Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Jan 12, 2024 | Substantially Equivalent | Anhui Powerguard Technology Co., Ltd. |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | Dec 28, 2023 | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. |
| K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | Dec 15, 2023 | Substantially Equivalent | Zibo Kaiyue Mould Technology Co., Ltd |
| K233042 | Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Dec 06, 2023 | Substantially Equivalent | Shandong Intco Medical Products Co, Ltd. |
| K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | Nov 28, 2023 | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. |
| K232576 | Medical Nitrile Examination Gloves | Nov 21, 2023 | Substantially Equivalent | Jiangsu Complete Sincerity Medical New Materials Co., Ltd. |
| K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | Nov 17, 2023 | Substantially Equivalent | WRP Asia Pacific Sdn. Bhd. |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | Nov 14, 2023 | Substantially Equivalent | Kossan International Sdn Bhd |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nov 03, 2023 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. |
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | Oct 30, 2023 | Substantially Equivalent | Zhonghong Pulin Medical Products Co.,Ltd. |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Oct 26, 2023 | Substantially Equivalent | Zhonghong Pulin Medical Products Co.,Ltd. |
| K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | Oct 20, 2023 | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | Oct 11, 2023 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. |
| K230777 | Patient Examination Gloves | Oct 06, 2023 | Substantially Equivalent | 3A Glove Sdn. Bhd. |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | Oct 04, 2023 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. |
| K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Oct 02, 2023 | Substantially Equivalent | Isikel Manufacturing LLC |
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Oct 02, 2023 | Substantially Equivalent | Central Medicare Sdn. Bhd. |
| K230847 | Chemotherapy Gloves | Sep 29, 2023 | Substantially Equivalent | 3A Glove Sdn. Bhd. |
| K223214 | Powder-Free Nitrile Examination Gloves | Sep 21, 2023 | Substantially Equivalent | Global Protection Corp. |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sep 08, 2023 | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. |
| K232353 | Powder Free Nitrile Examination Gloves (Black) | Aug 31, 2023 | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. |
| K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Aug 28, 2023 | Substantially Equivalent | Kimberly-Clark Corporation |
| K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Aug 24, 2023 | Substantially Equivalent | Shandong YINGHNG Medical Products Co., Ltd. |
| K230314 | Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) | Aug 16, 2023 | Substantially Equivalent | New Era Medicare Sdn. Bhd. |
| K231439 | Powder Free White, Black, and Purple Nitrile Examination Glove | Aug 11, 2023 | Substantially Equivalent | S&S Glove Corporation |
| K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Aug 11, 2023 | Substantially Equivalent | Shandong Intco Medical Products Co, Ltd. |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Aug 09, 2023 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. |
| K232008 | Disposable Medical Examination Nitrile Gloves | Aug 08, 2023 | Substantially Equivalent | Raxwell Industrial LLC |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Aug 07, 2023 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd |
| K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | Jul 24, 2023 | Substantially Equivalent | Central Medicare Sdn. Bhd. |
| K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Jul 21, 2023 | Substantially Equivalent | Kimberly-Clark Corporation |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Jul 20, 2023 | Substantially Equivalent | Central Medicare Sdn. Bhd. |
| K231740 | MemorialTM Gloves | Jul 04, 2023 | Substantially Equivalent | US Glove Supply |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jun 09, 2023 | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. |
| K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Jun 06, 2023 | Substantially Equivalent | Nephron Nitrile, LLC. |
| K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | Jun 05, 2023 | Substantially Equivalent | Dell Corning Corporation |
| K230542 | Disposable Nitrile Gloves (ABC-DG01) | May 31, 2023 | Substantially Equivalent | Huizhou Anboson Technology Co., Ltd. |
| K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | May 30, 2023 | Substantially Equivalent | First Glove Sdn. Bhd. |
| K230601 | Blue Nitrile Examination Gloves Powder Free | May 28, 2023 | Substantially Equivalent | Latrile Gloves Private Limited |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | May 23, 2023 | Substantially Equivalent | Central Medicare Sdn Bhd |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | May 17, 2023 | Substantially Equivalent | Hartalega NGC SDN. BHD. |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | May 15, 2023 | Substantially Equivalent | Careglove Global SDN. BHD. |
| K223280 | Disposible Nitrile Gloves | May 08, 2023 | Substantially Equivalent | HOLIK ASIA GROUP CO., LTD |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | Apr 27, 2023 | Substantially Equivalent | Guangdong Kingfa Sci. & Tech. Co., LTD. |
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mar 30, 2023 | Substantially Equivalent | Professional Latex Sdn Bhd |
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | Mar 25, 2023 | Substantially Equivalent | YTY Industry (Manjung) Sdn Bhd |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | Mar 24, 2023 | Substantially Equivalent | Mah Sing Healthcare Sdn Bhd |
| K223895 | Disposable Medical Nitrile Examination Gloves | Mar 23, 2023 | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. |
| K222813 | Nitrile Examination Gloves | Mar 16, 2023 | Substantially Equivalent | Ecoglove Medical Manufacturing Company Limited |
| K223375 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. | Mar 15, 2023 | Substantially Equivalent | Kossan International Sdn Bhd3 |
| K223102 | Tegamen Nitrile Examination Gloves | Mar 15, 2023 | Substantially Equivalent | M/S Tegamen Safety Products Private Limited |
| K223859 | Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | Feb 13, 2023 | Substantially Equivalent | Rhino Health Inc. |
| K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Feb 10, 2023 | Substantially Equivalent | Top Glove Medical (Thailand) Co., Ltd. |
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | Feb 09, 2023 | Substantially Equivalent | Nephron Pharmaceuticals Corporation |
| K223444 | Powder Free Blue Nitrile Examination Glove | Feb 06, 2023 | Substantially Equivalent | S&S Glove Corporation |
| K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) | Jan 27, 2023 | Substantially Equivalent | Semperit Investments Asia PTE LTD. |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jan 26, 2023 | Substantially Equivalent | Mah Sing Healthcare Sdn Bhd |
| K222531 | Synthetic Polymer Glove - Polyethylene (Black) | Jan 22, 2023 | Substantially Equivalent | UR Industry SDN BHD |
| K223250 | Disposable Nitrile Examination Glove | Jan 19, 2023 | Substantially Equivalent | Yangzhou Saraguard Medical Supplies Co.,Ltd. |
| K223748 | Nitrile Exam Gloves (Chemotherapy Drug Tested) | Jan 13, 2023 | Substantially Equivalent | US Medical Glove Company LLC |
| K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | Jan 13, 2023 | Substantially Equivalent | Dynacare Sdn Bhd |
| K222181 | Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate | Jan 11, 2023 | Substantially Equivalent | Iconic medicare sdn bhd |
| K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jan 04, 2023 | Substantially Equivalent | RMKH Glove (Cambodia) Co., Ltd. |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs | Dec 15, 2022 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd |
| K222527 | Nitrile Patient Examination Glove | Dec 14, 2022 | Substantially Equivalent | PingAn Medical Products Co.,Ltd. |
| K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Dec 11, 2022 | Substantially Equivalent | Inner Mongolia Boming Medical Supplies Co., Ltd. |
| K223281 | Disposable Nitrile Examination Glove | Dec 07, 2022 | Substantially Equivalent | Anhui Kindguard Medical Supplies Technology Co., Ltd |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | Dec 07, 2022 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN. BHD. |
| K223004 | Disposable Nitrile Examination Gloves | Dec 04, 2022 | Substantially Equivalent | Jiangxi Handspro Products Solutions CO., LTD. |
| K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | Dec 04, 2022 | Substantially Equivalent | Zibo Lanhua Medical Packaging Material Co., Ltd |
| K222720 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | Dec 03, 2022 | Substantially Equivalent | Safeskin Retailing (HK) Limited |
| K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Dec 03, 2022 | Substantially Equivalent | Safeskin Retailing (HK) Limited |
| K222713 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Dec 03, 2022 | Substantially Equivalent | Safeskin Retailing (HK) Limited |
| K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Dec 01, 2022 | Substantially Equivalent | Fitone Latex Products Co., Ltd. Guangdong |
| K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl | Nov 30, 2022 | Substantially Equivalent | Rhino Health Inc. |
| K222534 | Nitrile Patient Examination Glove | Nov 23, 2022 | Substantially Equivalent | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | Nov 20, 2022 | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited |
| K213981 | Nitrile Examination Gloves | Nov 12, 2022 | Substantially Equivalent | Emerald Glove Manufacturing Sdn Bhd |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | Nov 11, 2022 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Nov 07, 2022 | Substantially Equivalent | SafeSource Direct, LLC |
| K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nov 02, 2022 | Substantially Equivalent | Lingshi Hongruida Health Protection Technology Co., Ltd. |
| K220371 | Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Nov 02, 2022 | Substantially Equivalent | Summit Glove, Inc |
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nov 02, 2022 | Substantially Equivalent | Brightway Holdings Sdn. Bhd. |
| K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Oct 26, 2022 | Substantially Equivalent | PT. Sintong Unigolden Glove |
| K222498 | Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) | Oct 26, 2022 | Substantially Equivalent | Humanwell Healthcare Group Medical Supplies Co., Ltd. |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | Oct 25, 2022 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN.BHD. |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | Oct 21, 2022 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN.BHD. |
| K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Oct 18, 2022 | Substantially Equivalent | Safeskin Retailing (HK) Limited |
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Oct 18, 2022 | Substantially Equivalent | Onetexx SDN BHD |
| K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | Oct 17, 2022 | Substantially Equivalent | Zibo Langu New Material Technology Co., Ltd |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Oct 07, 2022 | Substantially Equivalent | Guang Dong Kingfa Sci. & Tech.Co., Ltd. |
| K222937 | Disposable Nitrile Examination Glove | Oct 01, 2022 | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. |
| K221378 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile | Sep 30, 2022 | Substantially Equivalent | Tec Gloves Industry (M) Sdn.Bhd. |
| K222342 | Betel Gloves Nitrile Examination Glove Powder Free | Sep 24, 2022 | Substantially Equivalent | Betel care Sdn. Bhd. |
| K222294 | Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Sep 24, 2022 | Substantially Equivalent | Onetexx SDN BHD |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | Sep 24, 2022 | Substantially Equivalent | Guangdong Kingfa Sci. & Tech. Co., Ltd. |
| K212751 | Powder Free Nitrile Examination Glove | Sep 24, 2022 | Substantially Equivalent | Dainam Glove Joint Stock Company |
| K222642 | Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) | Sep 20, 2022 | Substantially Equivalent | Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
| K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | Sep 20, 2022 | Substantially Equivalent | Mezorrison Medical Technology (Dongying) Co., Ltd. |
| K220697 | Nitrile Patient Examination Gloves, Powder Free | Sep 15, 2022 | Substantially Equivalent | Lalan Rubbers (Pvt) Ltd |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | Sep 09, 2022 | Substantially Equivalent | Careglove Global SDN BHD |
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | Aug 30, 2022 | Substantially Equivalent | Hong Seng Gloves SDN BHD |
| K221143 | Nitrile Exam Gloves (Blue, Black) | Aug 25, 2022 | Substantially Equivalent | Hebei Astro Medical Supply Co., Ltd. |
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | Aug 16, 2022 | Substantially Equivalent | O & M Halyard, Inc. |
| K213934 | Pro Guard Nitrile Powder Free Examination Glove | Aug 06, 2022 | Substantially Equivalent | Medical Glove Co., Ltd |
| K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Aug 05, 2022 | Substantially Equivalent | Rubberex Alliance Products Sdn Bhd |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | Aug 05, 2022 | Substantially Equivalent | Careglove Global SDN BHD |
| K220237 | Disposable Medical Nitrile Examination Gloves | Aug 01, 2022 | Substantially Equivalent | Fujian Jixiang Medical Technology Co.,Ltd |
| K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Aug 01, 2022 | Substantially Equivalent | O & M Halyard, Inc. |
| K221773 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid | Jul 30, 2022 | Substantially Equivalent | ONETEXX SDN BHD |
| K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Jul 27, 2022 | Substantially Equivalent | Shandong Maida Medical Technology Co.,Ltd. |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jul 27, 2022 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. |
| K221877 | Powder-Free Nitrile Examination Glove, Non-Sterile | Jul 23, 2022 | Substantially Equivalent | GoodGloves Industries Sdn Bhd |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | Jul 19, 2022 | Substantially Equivalent | ECO Medi Glove Sdn.Bhd. |
| K221229 | Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves | Jul 16, 2022 | Substantially Equivalent | Zibo Blue Sail Health Technology Co., Ltd |
| K221454 | Disposable Medical Nitrile Examination Gloves - Non Sterile | Jul 12, 2022 | Substantially Equivalent | Guangzhou Kangling Biotechnology Co., Ltd |
| K221108 | Nitrile Medical Examination Gloves | Jul 12, 2022 | Substantially Equivalent | Anhui Fulewei Electronic Technology Co.,Ltd |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | Jul 12, 2022 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd |
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | Jul 08, 2022 | Substantially Equivalent | American Nitrile Operations LLC |
| K220284 | Powder Free Nitrile Examination Gloves (Blue) | Jul 08, 2022 | Substantially Equivalent | KGM Gloves Sdn. Bhd. |
| K220834 | Powder Free Nitrile Examination Glove | Jun 29, 2022 | Substantially Equivalent | DAXWELL, LLC |
| K221192 | Disposable Nitrile Powder-Free Examination Gloves | Jun 22, 2022 | Substantially Equivalent | Shandong Maida Medical Technology Co.,Ltd. |
| K213739 | Nitrile Examination Gloves | Jun 22, 2022 | Substantially Equivalent | Hangzhou Runheng Medical Co., Ltd. |
| K220431 | Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile | Jun 17, 2022 | Substantially Equivalent | One Glove Industrial Sdn Bhd |
| K221226 | 1st Glove Blue Nitrile Examination Gloves Powder Free | Jun 16, 2022 | Substantially Equivalent | Koove Iot Pvt. Ltd. |
| K221186 | TC Gloves | Jun 16, 2022 | Substantially Equivalent | Thanh Cong Pharmaceutical and Trading Company Limited |
| K220693 | Zoupure Nitrile Powder Free Examination glove | Jun 07, 2022 | Substantially Equivalent | Thai Rayong Product Glove Zoupure Co., Ltd |
| K213448 | Powder Free Nitrile Gloves | Jun 06, 2022 | Substantially Equivalent | St Future International Limited |
| K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | Jun 03, 2022 | Substantially Equivalent | Riverstone Resources Sdn Bhd |
| K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | Jun 02, 2022 | Substantially Equivalent | O&M Halyard, Inc. |
| K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | Jun 02, 2022 | Substantially Equivalent | O&M Halyard, Inc. |
| K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Jun 01, 2022 | Substantially Equivalent | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. |
| K212699 | Disposable Powder Free Polyethylene Examination Gloves | May 31, 2022 | Substantially Equivalent | Mastermax Plastic (Huizhou) LTD |
| K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | May 28, 2022 | Substantially Equivalent | Shen Wei USA Inc. |
| K212584 | Blue Nitrile Examination Gloves Powder Free | May 28, 2022 | Substantially Equivalent | Amazing Rubber Products Pvt Ltd |
| K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | May 27, 2022 | Substantially Equivalent | Encompass Industries Sdn. Bhd. |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) | May 26, 2022 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd |
| K212629 | PP Care Nitrile Examination Gloves | May 26, 2022 | Substantially Equivalent | EG Group Product and Services CO., Ltd |
| K220155 | Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs | May 23, 2022 | Substantially Equivalent | Motex Healthcare (Anhui) Co., Ltd. |
| K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) | May 23, 2022 | Substantially Equivalent | PT. Shamrock Manufacturing Corpora |
| K220211 | Nitrile Powder Free Examination Gloves | May 18, 2022 | Substantially Equivalent | Hebei kangxida Medical Technology Development Co., Ltd. |
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | May 18, 2022 | Substantially Equivalent | Pt. Maja Agung Latexindo |
| K220429 | Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile | May 13, 2022 | Substantially Equivalent | One Glove Industrial SDN BHD |
| K220442 | Synguard Nitrile Exam Glove | May 12, 2022 | Substantially Equivalent | Tianjin Aoshang Outdoor Equipment Co., Ltd. |
| K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves | May 12, 2022 | Substantially Equivalent | KL-Kepong Rubber Products SDN. BHD. |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | May 11, 2022 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd |
| K220428 | Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile | May 10, 2022 | Substantially Equivalent | One Glove Industrial SDN BHD |
| K220427 | White Nitrile Powder-Free Patient Examination Glove, Non Sterile | May 10, 2022 | Substantially Equivalent | One Glove Industrial SDN BHD |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Apr 27, 2022 | Substantially Equivalent | Guang Dong Kingfa Sci. & Tech.Co., Ltd. |
| K220382 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple | Apr 21, 2022 | Substantially Equivalent | Jiangsu Bytech Medical Supplies Co.,Ltd. |
| K213681 | Ivory Glove Powder-Free Nitrile Examination Gloves | Apr 21, 2022 | Substantially Equivalent | Ivory Gloves SDN. BHD. |
| K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Apr 17, 2022 | Substantially Equivalent | Meditech Gloves SDN BHD |
| K220561 | Disposable Medical Nitrile Examination Gloves | Apr 14, 2022 | Substantially Equivalent | Nanjing universal medical equipment Co., Ltd |
| K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Apr 13, 2022 | Substantially Equivalent | Summit Glove, Inc |
| K220373 | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Apr 13, 2022 | Substantially Equivalent | Summit Glove, Inc |
| K220209 | Powder Free Nitrile Examination Glove, Non-sterile (Blue) | Apr 11, 2022 | Substantially Equivalent | KSG MEDICARE Sdn. Bhd. |
| K220121 | Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black | Apr 11, 2022 | Substantially Equivalent | AAMedix Glove Sdn Bhd |
| K213437 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Apr 11, 2022 | Substantially Equivalent | Central Medicare Sdn Bhd |
| K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim | Apr 09, 2022 | Substantially Equivalent | Riverstone Resources Sdn Bhd |
| K212929 | Nitrile Examination Gloves | Apr 09, 2022 | Substantially Equivalent | Watchtower PPE Supplies Inc. |
| K220066 | Medical Nitrile Examination Gloves | Apr 03, 2022 | Substantially Equivalent | Hunan Zhenheyikang Medical Instrument Co., Ltd |
| K213604 | ELAZ Nitrile Powder Free Examination Glove | Apr 03, 2022 | Substantially Equivalent | Protect Gloves Co., Ltd. |
| K220343 | Nitrile Examination Gloves | Apr 02, 2022 | Substantially Equivalent | NB Medical Co., LTD |
| K213843 | Nitrile Examination Gloves | Mar 31, 2022 | Substantially Equivalent | Dong Tai City Huayi Gloves Co.,Ltd. |
| K213662 | Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) | Mar 28, 2022 | Substantially Equivalent | Taishan Weibang Medical Equipment Co., Ltd. |
| K220229 | Powder Free Nitrile Examination Gloves, Orange | Mar 26, 2022 | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. |
| K220215 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) | Mar 26, 2022 | Substantially Equivalent | KSG MEDICARE Sdn. Bhd. |
| K213729 | Clover Glove | Mar 26, 2022 | Substantially Equivalent | Clover Glove Company Limited |
| K213848 | Medical nitrile examination gloves (Model: JL001) | Mar 25, 2022 | Substantially Equivalent | Guangdong Jiali Pharmaceutical Co.,Ltd |
| K220354 | Disposable Medical Synthetic Nitrile Examination Gloves | Mar 24, 2022 | Substantially Equivalent | Niujian Technology Co., Ltd |
| K212916 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Mar 24, 2022 | Substantially Equivalent | Rimba Glove SDN BHD |
| K213678 | Powder Free Blue Nitrile Examination Gloves | Mar 22, 2022 | Substantially Equivalent | Lienteh Technology Sdn Bhd |
| K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | Mar 18, 2022 | Substantially Equivalent | Shandong Blue Sail Health Technology Co., Ltd |
| K213121 | Disposable Nitrile Examination Glove | Mar 15, 2022 | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. |
| K213373 | Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mar 10, 2022 | Substantially Equivalent | Smart Glove Corporation Sdn.Bhd. |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | Mar 10, 2022 | Substantially Equivalent | Ansell Healthcare Products LLC |
| K213851 | Disposable Medical Nitrile gloves | Mar 09, 2022 | Substantially Equivalent | Guangdong Xingcan Brothers Medical Technology Co.,Ltd |
| K211808 | Medcare Powder-Free Blue Nitrile Patient Examination Gloves | Mar 04, 2022 | Substantially Equivalent | Dongguan Grinvald Technology Co., Ltd. |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Mar 04, 2022 | Substantially Equivalent | WRP Asia Pacific SDN BHD |
| K212833 | Disposable Nitrile Examination Gloves | Feb 28, 2022 | Substantially Equivalent | Chifeng Huawei Medical Science & Technology Co., Ltd |
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | Feb 21, 2022 | Substantially Equivalent | Mercator Medical (Thailand) LTD |
| K213500 | TMG Nitrile Powder Free Examination Glove | Feb 21, 2022 | Substantially Equivalent | Thai Medical Glove Co., Ltd. |
| K220232 | Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange | Feb 20, 2022 | Substantially Equivalent | Megine Industries Sdn Bhd |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | Feb 19, 2022 | Substantially Equivalent | Mah Sing Healthcare Sdn Bhd |
| K213912 | Disposable Medical Nitrile Examination Gloves | Feb 19, 2022 | Substantially Equivalent | Jiangsu Maolin Medical Technology Co., Ltd |
| K213600 | Medical nitrile examination gloves (Model: SH001) | Feb 19, 2022 | Substantially Equivalent | Jiangxi SanHao Medical Instruments Co.,Ltd |
| K213286 | EONS Nitrile Examination Gloves Powder Free | Feb 19, 2022 | Substantially Equivalent | Eons Gloves (Thailand) Co., Ltd |
| K212998 | Powder Free Nitrile Examination Gloves (White, Blue and Black) | Feb 19, 2022 | Substantially Equivalent | Alcatron Gloves Factory |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | Feb 18, 2022 | Substantially Equivalent | Wuhan Zonsen Medical Products Co.,Ltd |
| K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs | Feb 18, 2022 | Substantially Equivalent | Luliang Hongruida Health Protection Technology Co., Ltd. |
| K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs | Feb 18, 2022 | Substantially Equivalent | Zibo Sinocare Plastic Products Co., Ltd |
| K213107 | Powder Free Blue Nitrile Examination Gloves | Feb 17, 2022 | Substantially Equivalent | Novid PPE Sdn. Bhd. |
| K212586 | Amazing+ | Feb 17, 2022 | Substantially Equivalent | Amazing Rubber Products Pvt Ltd |
| K213058 | O'Star Nitrile Examination Gloves Powder Free | Feb 08, 2022 | Substantially Equivalent | Star Investment And Trade Joint Stock Company |
| K213142 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution | Jan 28, 2022 | Substantially Equivalent | Shen Wei USA Inc. |
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Jan 23, 2022 | Substantially Equivalent | Xuzhou Full Sun Medical Products Ltd. |
| K213044 | Nitrile Examination Gloves | Jan 21, 2022 | Substantially Equivalent | Jiangsu Huayuan Medical Technology Co., Ltd. |
| K211864 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Jan 21, 2022 | Substantially Equivalent | Siyang Jaysun Medtech Co., Ltd. |
| K213075 | Goody Gloves, Wincare, TBG Gloves | Jan 20, 2022 | Substantially Equivalent | Thai Rubber Gloves Co., Ltd. |
| K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) | Jan 19, 2022 | Substantially Equivalent | Uweport LLC. |
| K211003 | SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove | Jan 19, 2022 | Substantially Equivalent | Showa Best Glove, Inc. |
| K211360 | Disposable Nitrile Powder Free Examination Gloves (Non-sterile) | Jan 15, 2022 | Substantially Equivalent | Pt. Universal Gloves |
| K213859 | Stronghold Group Nitrile Examination Glove, Powder Free | Jan 13, 2022 | Substantially Equivalent | Stronghold Group LLC |
| K213168 | Medical Examination Gloves | Jan 11, 2022 | Substantially Equivalent | Shandong Huiwosheng Health Technology Co.,Ltd |
| K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | Jan 11, 2022 | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. |
| K212801 | Powder free nitrile examination glove- black, non sterile | Jan 09, 2022 | Substantially Equivalent | Hong Seng Gloves Sdn Bhd |
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | Jan 09, 2022 | Substantially Equivalent | Careglove Global SDN. BHD. |
| K212847 | Penta Glove | Jan 06, 2022 | Substantially Equivalent | Pentavest Holdings Sdn Bhd |
| K213187 | Disposable Nitrile Medical Powder-free Glove | Jan 03, 2022 | Substantially Equivalent | Fujian Chunhui Medical Supply Co., Ltd. |
| K212834 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | Dec 30, 2021 | Substantially Equivalent | Siyang Threeguard Medical Supplies Co.,Ltd. |
| K213016 | ATM Glove | Dec 28, 2021 | Substantially Equivalent | Phu Duc Huy Production Trading Services Corporation |
| K212716 | Dermoaroma Disposable Nitrile Examination Glove | Dec 27, 2021 | Substantially Equivalent | ChuZhou Harmony Gloves Medical Technology Co.,Ltd |
| K212921 | Nitrile Examination Golves Powder Free | Dec 24, 2021 | Substantially Equivalent | Jiangsu Standard Health Co.,Ltd |
| K212914 | Glovmaster Nitrile Examination Glove Powder Free | Dec 22, 2021 | Substantially Equivalent | Glovmaster SDN. BHD. |
| K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | Dec 22, 2021 | Substantially Equivalent | Central Medicare Sdn Bhd |
| K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) | Dec 21, 2021 | Substantially Equivalent | Koon Seng Sdn Bhd |
| K213051 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | Dec 18, 2021 | Substantially Equivalent | Yunnan Huazhiyuan Medical Technology Co., Ltd. |
| K213048 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | Dec 18, 2021 | Substantially Equivalent | Huayuan Medical Technology(Shangqiu) Co., Ltd. |
| K211624 | USA Gloves Nitrile Powder Free Exam Gloves | Dec 18, 2021 | Substantially Equivalent | USA Gloves |
| K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | Dec 18, 2021 | Substantially Equivalent | Ammex Corporation |
| K211209 | Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves | Dec 17, 2021 | Substantially Equivalent | Hycare International Co., Ltd |
| K212898 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs | Dec 16, 2021 | Substantially Equivalent | Rimba Glove SND BHD |
| K212645 | AT | Dec 16, 2021 | Substantially Equivalent | AT Glove Engineering SDN. BHD |
| K212919 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Dec 15, 2021 | Substantially Equivalent | Jiujiang Taixin Technology Co., Ltd. |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | Dec 14, 2021 | Substantially Equivalent | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
| K213176 | Disposable Nitrile Powder-Free Examination Gloves | Dec 13, 2021 | Substantially Equivalent | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. |
| K212924 | Nitrile Examination Gloves | Dec 13, 2021 | Substantially Equivalent | Shanxi Nacosa Medical Technology Co.,Ltd |
| K210388 | Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color | Dec 13, 2021 | Substantially Equivalent | Mexpo International Inc. |
| K212840 | Nitrile Gloves (Model: NE01) | Dec 11, 2021 | Substantially Equivalent | BYD Auto Industry Company Limited |
| K212182 | Iconic Nitrile Glove | Dec 11, 2021 | Substantially Equivalent | Iconic Medicare Sdn Bhd |
| K212085 | Siam NTD+ Nitrile Powder-Free Examination gloves | Dec 11, 2021 | Substantially Equivalent | Siam NTD Corporation Co., Ltd. |
| K212922 | Nitrile Examination Gloves | Dec 10, 2021 | Substantially Equivalent | HSK Medical Apparatus Foshan China Co. LTD |
| K212850 | ComfortPro Blue Nitrile Examination Gloves Powder Free | Dec 10, 2021 | Substantially Equivalent | Thai Rubber Industry Company Limited |
| K212349 | Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves | Dec 10, 2021 | Substantially Equivalent | Medi Legion Sdn.Bhd |
| K213371 | Disposable Medical Nitrile Examination Gloves (Model:XYS-001) | Dec 09, 2021 | Substantially Equivalent | Anhui Xinyisheng Medical Technology Co.,Ltd |
| K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | Dec 04, 2021 | Substantially Equivalent | Mah Sing Healthcare Sdn Bhd |
| K212802 | powder free nitrile examination glove - white, non-sterile | Dec 02, 2021 | Substantially Equivalent | Hong Seng Gloves Sdn Bhd |
| K212578 | Nitrile disposable examination gloves | Dec 02, 2021 | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. |
| K212804 | Powder free nitrile examination glove- blue, non-sterile | Dec 01, 2021 | Substantially Equivalent | Hong Seng Gloves Sdn Bhd |
| K212789 | Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Dec 01, 2021 | Substantially Equivalent | 5R MED Instruments (CHENGDU) Co., Ltd. |
| K212722 | Nitrile Examination Gloves | Nov 26, 2021 | Substantially Equivalent | Wuhan Huirui Technology Co., Ltd |
| K210990 | Non-sterile Powder Free Nitrile Examination Gloves | Nov 22, 2021 | Substantially Equivalent | Rubberex Alliance Sdn Bhd |
| K212661 | Disposable Nitrile Examination Glove | Nov 19, 2021 | Substantially Equivalent | Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
| K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | Nov 19, 2021 | Substantially Equivalent | O & M Halyard, Inc. |
| K212600 | Disposable Medical Nitrile Examination Gloves (Non-sterile) | Nov 18, 2021 | Substantially Equivalent | Suqian Linglian Medical Technology Co., Ltd |
| K212029 | Disposable Medical Nitrile Examination Gloves (non-sterile) | Nov 16, 2021 | Substantially Equivalent | Taizhou Kangjian Medical Equipments Co., Ltd. |
| K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) | Nov 11, 2021 | Substantially Equivalent | CRDLight Optoelectronic Technology Co., Ltd |
| K212497 | Nitrile Examination Glove (Powder free, Blue) | Nov 11, 2021 | Substantially Equivalent | Jiangsu Jinlian Medical Technology Co., Ltd |
| K210779 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Nov 10, 2021 | Substantially Equivalent | Shandong Shangwei Medical Products Co.,Ltd |
| K212506 | Medical Examination Gloves (Tested for Use with Chemotherapy) | Nov 07, 2021 | Substantially Equivalent | GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD |
| K212551 | Nitrile Examination Gloves | Nov 05, 2021 | Substantially Equivalent | Anhui Fine Glove Medical Technology Co., Ltd |
| K212485 | Disposable Nitrile Examination gloves | Nov 05, 2021 | Substantially Equivalent | Fujian Yuanxin Safety Protection Technology Co., Ltd. |
| K212467 | Disposable Nitrile Examination Glove | Nov 04, 2021 | Substantially Equivalent | Inner Mongolia Boming Medical Supplies Co., Ltd. |
| K210777 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Nov 02, 2021 | Substantially Equivalent | Shandong Jieshi Medical Products Co.,Ltd |
| K211586 | Nitrile Examination Gloves (Blue, Violet) | Nov 01, 2021 | Substantially Equivalent | Lyncmed Medical Technology (Beijing) Co., Ltd. |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Oct 31, 2021 | Substantially Equivalent | Onetexx SDN BHD |
| K212308 | SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free | Oct 29, 2021 | Substantially Equivalent | Srirungruang Global Co., LTD. |
| K212290 | Examination gloves -Type C (Nitrile gloves) | Oct 28, 2021 | Substantially Equivalent | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
| K211581 | Disposable Nitrile Examination Gloves (Powder free, Blue) | Oct 28, 2021 | Substantially Equivalent | Leping Shengde Medical Technology Company Limited |
| K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | Oct 27, 2021 | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. |
| K212363 | Disposable Medical Nitrile Examination Gloves | Oct 26, 2021 | Substantially Equivalent | Lanhuo Medical Technology (Jiangsu) Co.,Ltd |
| K212401 | Disposable Nitrile Examination Glove | Oct 25, 2021 | Substantially Equivalent | Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
| K210249 | Best Glove-Nitrile Powder Free Examination Glove | Oct 25, 2021 | Substantially Equivalent | Bestsafe Glove CO., LTD |
| K212311 | Medical Examination Gloves | Oct 21, 2021 | Substantially Equivalent | Guangzhou Junda Gloves Co., Ltd |
| K210706 | Nitrile Examination Gloves | Oct 19, 2021 | Substantially Equivalent | Niujian Technology Co., Ltd. |
| K211914 | Nitrile Patient Examination Gloves | Oct 14, 2021 | Substantially Equivalent | Yingxiang Glove Products Co., Ltd. |
| K212014 | Medical Nitrile Examination Gloves | Oct 13, 2021 | Substantially Equivalent | Jiangxi Ronglai Medical Technology Co., Ltd. |
| K211374 | Proclean - Nitrile Powder Free Examination Gloves | Oct 13, 2021 | Substantially Equivalent | Dr.Boo Company Limited |
| K211927 | Nitrile examination gloves | Oct 12, 2021 | Substantially Equivalent | Fitone Latex Products Co., Ltd. Guangdong |
| K212078 | Medical Examination Gloves | Oct 08, 2021 | Substantially Equivalent | Guangdong Gymda Medical Technology Co., Ltd |
| K211719 | ZinRom Nitrile examination gloves | Oct 06, 2021 | Substantially Equivalent | Changzhou Xingrong Medical Technology Co. LTD |
| K212036 | Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs | Oct 05, 2021 | Substantially Equivalent | Jiangsu Yanfang Medical Technology Co., Ltd. |
| K211781 | Disposable Nitrile Gloves | Sep 29, 2021 | Substantially Equivalent | Jiangsu Jinke Protective Equipment Co., Ltd |
| K211073 | Disposable Nitrile Examination Gloves | Sep 21, 2021 | Substantially Equivalent | Foshan Kangkang Biotechnology Co., LTD |
| K211479 | Blue Nitrile Examination Glove Powder Free | Sep 16, 2021 | Substantially Equivalent | Aspen Glove Sdn. Bhd. |
| K212009 | Disposable Nitrile Gloves | Sep 15, 2021 | Substantially Equivalent | Jiangsu Shenglijie Safety Products Co., Ltd |
| K211778 | Nitrile Examination Gloves, Green/ Blue/ Black Color | Sep 02, 2021 | Substantially Equivalent | Zhenjiang SuHui Latex Products Co., Ltd. |
| K210868 | Nitrile Examination Gloves Powder Free (Blue) | Sep 02, 2021 | Substantially Equivalent | Great Eco Glove Sdn. Bhd. |
| K211673 | Disposable Medical Nitrile Gloves | Sep 01, 2021 | Substantially Equivalent | Changzhou Yihua Sanitation Material Co., Ltd |
| K211390 | Nitrile Blue Powder-free Examination Glove | Aug 28, 2021 | Substantially Equivalent | Cardinal Health 200, LLC |
| K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Aug 26, 2021 | Substantially Equivalent | Tangshan Lanhai Medical Supplies Co., Ltd. |
| K211515 | Nitrile Examination Gloves | Aug 24, 2021 | Substantially Equivalent | Beijing Reagent Latex Products Co., Ltd. |
| K210897 | Disposable Nitrile Examination Gloves | Aug 24, 2021 | Substantially Equivalent | Shandong DS Safety Technology Co., Ltd. |
| K211699 | Nitrile Exam Gloves, Powder Free, Blue | Aug 20, 2021 | Substantially Equivalent | Hengchang (Dongying) Medical Technology Co.,Ltd. |
| K203622 | Medical Gloves | Aug 20, 2021 | Substantially Equivalent | Beijing Biosis Healing Biological Technology Co., Ltd. |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Aug 20, 2021 | Substantially Equivalent | Careplus (M) SDN BHD |
| K211319 | Purism Non-Sterile Powder Free Nitrile Examination Gloves | Aug 19, 2021 | Substantially Equivalent | Dezhou Purism Medical Technology Co., Ltd. |
| K211708 | Disposable Medical Nitrile Gloves | Aug 17, 2021 | Substantially Equivalent | Jiangsu Health-Peace Medical Technology Co. Ltd |
| K203236 | Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove | Aug 16, 2021 | Substantially Equivalent | Rhino Health Inc |
| K211860 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Aug 13, 2021 | Substantially Equivalent | Anhui Powerguard Technology Co., Ltd. |
| K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | Aug 11, 2021 | Substantially Equivalent | YTY Industry (Manjung) SDN BHD |
| K210730 | Nitrile Patient Examination Glove | Aug 10, 2021 | Substantially Equivalent | American Performance Polymers, LLC |
| K211540 | Edma Synthetic Nitrile Examination Gloves | Aug 09, 2021 | Substantially Equivalent | Edma Group, LLC |
| K210725 | Nitrile Patient Examination Glove | Aug 06, 2021 | Substantially Equivalent | PingAn Medical Products Co.,Ltd. |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | Aug 05, 2021 | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. |
| K211434 | Nitrile Patient Examination Gloves | Aug 05, 2021 | Substantially Equivalent | Zhangjiagang Huayuan Protective Equipment Co., Ltd. |
| K211075 | Disposable Medical Nitrile Examination Gloves (Non-Sterile) | Aug 05, 2021 | Substantially Equivalent | Jiangsu Cherish Medical Technology Co., Ltd |
| K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) | Aug 04, 2021 | Substantially Equivalent | Hengchang (Dongying) Medical Technology Co., Ltd. |
| K211182 | H2H Powder Free Examination Blue Glove | Aug 01, 2021 | Substantially Equivalent | NTL Innovation Co., Ltd. |
| K211264 | Disposable Nitrile Examination Gloves | Jul 30, 2021 | Substantially Equivalent | Shenzhen Shiqiao Science and Technology Co. LTD |
| K210691 | Disposable Nitrile Medical Examination Glove | Jul 30, 2021 | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. |
| K211341 | Blue Nitrile Exam Gloves | Jul 29, 2021 | Substantially Equivalent | Jiangxi Surefine Medical Co., Ltd. |
| K211131 | Disposable Nitrile Medical Examination Glove | Jul 29, 2021 | Substantially Equivalent | Siyang Threeguard Medical Supplies Co.,Ltd. |
| K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | Jul 28, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K211012 | Nitrile Patient Examination Gloves | Jul 23, 2021 | Substantially Equivalent | Huayuan Medical Technology(Shangqiu) Co., Ltd. |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs | Jul 22, 2021 | Substantially Equivalent | Guangdong Kingfa Sci. & Tech. Co., Ltd. |
| K210686 | Nitrile Patient Examination Glove | Jul 21, 2021 | Substantially Equivalent | Yunnan Huazhiyuan Medical Technology Co., Ltd. |
| K210684 | Disposable Nitrile Medical Examination Glove | Jul 20, 2021 | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. |
| K211547 | Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Jul 15, 2021 | Substantially Equivalent | Edma Group, LLC |
| K210776 | Nitrile Examination Gloves | Jul 12, 2021 | Substantially Equivalent | 5R MED Instruments (Chengdu) Co., Ltd. |
| K210723 | Nitrile Patient Examination Glove | Jul 12, 2021 | Substantially Equivalent | Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | Jul 10, 2021 | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group Ltd. |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Jun 28, 2021 | Substantially Equivalent | Onetexx SDN BHD |
| K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Jun 28, 2021 | Substantially Equivalent | Onetexx SDN BHD |
| K211252 | Nitrile Glove | Jun 25, 2021 | Substantially Equivalent | Jiangsu Dihong Industry and Trade Co., Ltd. |
| K201428 | Powder Free Black Nitrile Examination Glove | Jun 24, 2021 | Substantially Equivalent | Vietglove Corporation |
| K210375 | Powder Free Blue Nitrile Examination Glove | Jun 21, 2021 | Substantially Equivalent | Duramitt sdn Bhd |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | Jun 21, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K211310 | AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) | Jun 16, 2021 | Substantially Equivalent | Megine Industries Sdn Bhd |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jun 13, 2021 | Substantially Equivalent | Ansell Healthcare Products LLC |
| K211028 | Nitrile Patient Examination Gloves | Jun 04, 2021 | Substantially Equivalent | Huayuan Medical Technology(Shangqiu) Co., Ltd. |
| K210369 | Powder Free Nitrile Examination Glove | May 13, 2021 | Substantially Equivalent | Pastel Glove Sdn Bhd |
| K210755 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) | May 07, 2021 | Substantially Equivalent | Meditech Gloves SDN BHD |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | May 07, 2021 | Substantially Equivalent | Onetexx SDN BHD |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | May 07, 2021 | Substantially Equivalent | Central Medicare Sdn Bhd |
| K210944 | Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) | Apr 29, 2021 | Substantially Equivalent | Harbour Health LLC |
| K203436 | Disposable Nitrile Examination Gloves | Apr 28, 2021 | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd |
| K203512 | Powder Free Blue Nitrile Examination Glove | Apr 26, 2021 | Substantially Equivalent | VIP Glove SDN BHD |
| K210145 | Nitrile Glove Powder Free Blue | Apr 21, 2021 | Substantially Equivalent | Changzhou Universal Medical Equipment CO. LTD. |
| K203805 | Disposable Nitrile Examination Gloves | Apr 20, 2021 | Substantially Equivalent | Jiangsu Yanfang Medical Technology Co., Ltd. |
| K210276 | Disposable Nitrile Gloves | Apr 16, 2021 | Substantially Equivalent | Fujian Ercon Medical Management Co., Ltd. |
| K202419 | BIOTECH Nitrile Examination Gloves | Apr 16, 2021 | Substantially Equivalent | TK Hitech Technology Co., Ltd. |
| K210106 | Nitrile Examination Gloves | Apr 07, 2021 | Substantially Equivalent | Zhenjiang Huayang Latex Products Co., Ltd. |
| K210057 | Blue Nitrile Exam Glove, Powder Free | Mar 31, 2021 | Substantially Equivalent | Real Star Medical Technology Co., Ltd. |
| K210058 | Blue Nitrile Exam Glove, Powder Free | Mar 30, 2021 | Substantially Equivalent | Great Harvest Trading Co., Ltd. |
| K202083 | Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | Mar 25, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | Mar 24, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K203593 | Patient Examination Gloves | Mar 19, 2021 | Substantially Equivalent | Guang Dong Kingfa SCI. & TECH.CO., LTD. |
| K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | Mar 19, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202082 | Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid | Mar 17, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202086 | Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors | Mar 16, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove | Mar 05, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors | Mar 05, 2021 | Substantially Equivalent | Shen Wei USA Inc. |
| K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Mar 02, 2021 | Substantially Equivalent | Kanglongda Vietnam Protection Technology Company Limited |
| K202402 | Nitrile Examination Gloves (Blue, Violet Blue, White) | Mar 01, 2021 | Substantially Equivalent | Jiangsu Tianshuo Medical Products Co., Ltd. |
| K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Feb 24, 2021 | Substantially Equivalent | GMP Medicare SDN BHD |
| K203191 | LYDUS Nitrile Examination Gloves, Powder Free | Feb 12, 2021 | Substantially Equivalent | Nathan Trading Co., Ltd |
| K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | Jan 07, 2021 | Substantially Equivalent | O & M Halyard, Inc. |
| K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | Dec 02, 2020 | Substantially Equivalent | Hi-Care Thai Gloves Co. Ltd. |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | Nov 30, 2020 | Substantially Equivalent | Kimberly Clark Corporation |
| K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) | Oct 26, 2020 | Substantially Equivalent | Medline Industries Inc |
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | Sep 22, 2020 | Substantially Equivalent | O&M Halyard, Inc. |
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | Sep 03, 2020 | Substantially Equivalent | Top Glove SDN BHD |
| K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Aug 25, 2020 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K200093 | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | Aug 20, 2020 | Substantially Equivalent | Anhui lntco Medical Products Co., Ltd. |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Aug 05, 2020 | Substantially Equivalent | Hartalega SDN. BHD. |
| K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | Aug 05, 2020 | Substantially Equivalent | Hartalega Ngc Sdn. Bhd. |
| K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff | Aug 04, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Jul 13, 2020 | Substantially Equivalent | Medline Industires, Inc. |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | Jun 19, 2020 | Substantially Equivalent | Ansell Healthcare Products LLC |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | Jun 19, 2020 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | Jun 06, 2020 | Substantially Equivalent | Mercator Medical (Thailand) LTD. |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | Jun 05, 2020 | Substantially Equivalent | Top Glove SDN BHD |
| K200453 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | May 01, 2020 | Substantially Equivalent | YTY Industry (Manjung) Sdn Bhd |
| K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Apr 25, 2020 | Substantially Equivalent | Hartalega NGC SDN. BHD. |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Apr 15, 2020 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | Apr 10, 2020 | Substantially Equivalent | Kimberly-Clark Corporation |
| K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | Apr 09, 2020 | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited |
| K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Apr 09, 2020 | Substantially Equivalent | Riverstone Resources SDN BHD |
| K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | Apr 06, 2020 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | Mar 20, 2020 | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited |
| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | Mar 20, 2020 | Substantially Equivalent | ECO Medi Glove SDN BHD |
| K191753 | Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) | Mar 17, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mar 13, 2020 | Substantially Equivalent | O & M Haylard, Inc. |
| K192333 | Blue Nitrile Examination Gloves Powder Free | Jan 24, 2020 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN.BHD. |
| K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | Jan 17, 2020 | Substantially Equivalent | WRP ASIA PACIFIC SDN BHD |
| K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) | Jan 10, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Jan 07, 2020 | Substantially Equivalent | Ever Growth (Vietnam) Co. Ltd. |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | Dec 31, 2019 | Substantially Equivalent | Mercator Medical (Thailand) LTD. |
| K192104 | Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) | Dec 23, 2019 | Substantially Equivalent | Medline Industries, Inc. |
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color | Dec 23, 2019 | Substantially Equivalent | Ever Growth (Vietnam) Co. Ltd. |
| K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | Dec 23, 2019 | Substantially Equivalent | Ever Growth (Vietnam) Co. Ltd. |
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | Dec 17, 2019 | Substantially Equivalent | Riverstone Resources SDN BHD |
| K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed | Dec 02, 2019 | Substantially Equivalent | Mercator Medical (Thailand) LTD. |
| K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | Nov 08, 2019 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | Oct 04, 2019 | Substantially Equivalent | Semperit Investments Asia PTE LTD. |
| K190466 | PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate | Sep 26, 2019 | Substantially Equivalent | Shen Wei USA Inc. |
| K190454 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff | Sep 26, 2019 | Substantially Equivalent | Hartalega Ngc Sdn. Bhd. |
| K191800 | Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim | Sep 16, 2019 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | Sep 06, 2019 | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation |
| K182089 | Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs | Jul 30, 2019 | Substantially Equivalent | Platinum Glove Industries Sdn Bhd |
| K183280 | PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs | Jul 26, 2019 | Substantially Equivalent | Smart Glove Corporation Sdn. Bhd. |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | Jun 27, 2019 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Jun 26, 2019 | Substantially Equivalent | O & M Halyard, Inc. |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | Jun 20, 2019 | Substantially Equivalent | GX Corporation SDN BHD |
| K182308 | Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs | May 30, 2019 | Substantially Equivalent | Sri Trang Gloves (Thailand) Co., LTD. |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | May 28, 2019 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K182612 | Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) | May 10, 2019 | Substantially Equivalent | Zibo Yahao Supplies Co., LTD |
| K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | Apr 12, 2019 | Substantially Equivalent | Shandong Hengya Packaging Printing Co.,Ltd |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Apr 05, 2019 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | Mar 22, 2019 | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd |
| K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | Mar 11, 2019 | Substantially Equivalent | Sri Trang Gloves (Thailand) Co., LTD |
| K181106 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Jan 16, 2019 | Substantially Equivalent | JiangSu DongXin Medical Technology Co., Ltd |
| K183068 | Nitrile Glove Powder Free White | Dec 21, 2018 | Substantially Equivalent | Haining Medical Products Co., Ltd. |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | Nov 30, 2018 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nov 20, 2018 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | Nov 16, 2018 | Substantially Equivalent | Hartalega Sdn Bhd |
| K182528 | Nitrile Glove Powder Free Black | Nov 15, 2018 | Substantially Equivalent | Haining Medical Products Co., Ltd. |
| K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | Nov 02, 2018 | Substantially Equivalent | Owens & Minor Halyard, Inc. |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff | Nov 02, 2018 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K180468 | SBG Black Nitrile Powder Free Medical Examination Glove | Oct 10, 2018 | Substantially Equivalent | Showa Best Glove, Inc. |
| K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Oct 10, 2018 | Substantially Equivalent | Showa Best Glove, Inc |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | Sep 26, 2018 | Substantially Equivalent | ECO Medi Glove Sdn Bhd |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | Aug 17, 2018 | Substantially Equivalent | Hartalega Sdn. Bhd. |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Aug 10, 2018 | Substantially Equivalent | Hartalega Sdn Bhd |
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | Jul 05, 2018 | Substantially Equivalent | MULTISAFE SDN. BHD. |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | Jun 14, 2018 | Substantially Equivalent | Hartalega Sdn. Bhd. |
| K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Jun 12, 2018 | Substantially Equivalent | Riverstone Resources SDN BHD |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Jun 11, 2018 | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp |
| K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | May 10, 2018 | Substantially Equivalent | GMP MEDICARE SDN BHD (F25) |
| K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) | Apr 30, 2018 | Substantially Equivalent | Medline Industries, Inc. |
| K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | Apr 26, 2018 | Substantially Equivalent | Top Glove Sdn. Bhd. |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Apr 13, 2018 | Substantially Equivalent | Mercator Medical (Thailand) LTD. |
| K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | Feb 22, 2018 | Substantially Equivalent | Koon Seng Sdn. Bhd. |
| K173228 | U-MED Powder Free Polyethylene Examination Gloves,Blue Color | Feb 20, 2018 | Substantially Equivalent | Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | Dec 29, 2017 | Substantially Equivalent | Ansell Healthcare Products LLC |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | Dec 12, 2017 | Substantially Equivalent | Hartalega Sdn. Bhd. |
| K172678 | THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE | Nov 24, 2017 | Substantially Equivalent | Shen Wei USA Inc. |
| K171743 | Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves | Nov 17, 2017 | Substantially Equivalent | Smart Glove Corporation Sdn.Bhd |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | Nov 15, 2017 | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. |
| K172442 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Nov 06, 2017 | Substantially Equivalent | Hartalega NGC SDN. BHD. |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | Oct 12, 2017 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K171782 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs | Oct 12, 2017 | Substantially Equivalent | Blue Sail Medical Co.,Ltd |
| K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | Sep 26, 2017 | Substantially Equivalent | Careglove Global Sdn Bhd |
| K171541 | Powder Free Nitrile Examination Gloves (Orange) | Sep 20, 2017 | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. |
| K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs | Sep 14, 2017 | Substantially Equivalent | SEMPERIT INVESTMENTS ASIA PTE. LTD. |
| K171667 | Powder Free Nitrile Examination Glove | Sep 08, 2017 | Substantially Equivalent | Professional Latex Sdn Bhd |
| K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | Aug 25, 2017 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN BHD |
| K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Aug 25, 2017 | Substantially Equivalent | SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD |
| K171615 | Xingyu Nitrile Powder Free Patient Examination Gloves, White color | Jul 31, 2017 | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd |
| K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | Jul 25, 2017 | Substantially Equivalent | SHEN WEI USA INC. |
| K171616 | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color | Jul 20, 2017 | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd |
| K171093 | STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE | Jul 19, 2017 | Substantially Equivalent | Sanrea Healthcare Products Pvt Ltd |
| K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | Jul 18, 2017 | Substantially Equivalent | UG GLOBAL RESOURCES SDN. BHD. |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | Jul 14, 2017 | Substantially Equivalent | Brightway Holdings Sdn. Bhd. |
| K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs | Jul 10, 2017 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs | Jul 07, 2017 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD |
| K163035 | DilaCheck Nitrile Powder Free Examination Glove, (Sterile) | Jul 07, 2017 | Substantially Equivalent | Elm Tree Medical, Inc. |
| K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) | Jun 30, 2017 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | May 24, 2017 | Substantially Equivalent | Shen Wei USA Inc. |
| K163553 | Powder Free Nitrile Patient Examination Gloves, Blue | May 22, 2017 | Substantially Equivalent | HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD. |
| K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | May 09, 2017 | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd |
| K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Apr 21, 2017 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN BHD. |
| K162626 | THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE | Mar 31, 2017 | Substantially Equivalent | TOP QUALITY GLOVE SDN. BHD |
| K161929 | Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove | Mar 29, 2017 | Substantially Equivalent | Dipped Products (Thailand) Limited |
| K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) | Mar 28, 2017 | Substantially Equivalent | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
| K163267 | NITRILE EXAMINATION GLOVE | Mar 24, 2017 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN BHD |
| K162646 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Mar 03, 2017 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) | Feb 27, 2017 | Substantially Equivalent | Medline Industries, Inc. |
| K161099 | Powder Free Nitrile Examination Gloves, Black | Feb 23, 2017 | Substantially Equivalent | PT. MAJA AGUNG LATEXINDO |
| K163126 | Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) | Feb 22, 2017 | Substantially Equivalent | Blue Sail Medical Co., Ltd |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E | Feb 22, 2017 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Feb 08, 2017 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | Feb 06, 2017 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K162381 | HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs | Jan 31, 2017 | Substantially Equivalent | HEALTHY GLOVE CO., LTD |
| K162924 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) | Jan 24, 2017 | Substantially Equivalent | HARTALEGA SDB. BHD. |
| K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | Jan 09, 2017 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Jan 09, 2017 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | Jan 05, 2017 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN BHD. |
| K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | Dec 21, 2016 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN BHD |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink | Nov 28, 2016 | Substantially Equivalent | Terang Nusa Sdn Bhd |
| K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Nov 21, 2016 | Substantially Equivalent | SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. |
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Nov 17, 2016 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K162113 | Powder Free Nitrile Examination Gloves (Blue) | Nov 07, 2016 | Substantially Equivalent | NAM VIET GLOVE JOINT STOCK COMPANY |
| K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | Nov 02, 2016 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD., |
| K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Oct 20, 2016 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K161473 | Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) | Oct 19, 2016 | Substantially Equivalent | MEDLINE, INDUSTRIES, INC. |
| K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | Oct 13, 2016 | Substantially Equivalent | HARTALEGA SND. BHD. |
| K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs | Sep 09, 2016 | Substantially Equivalent | ECO MEDI GLOVE SDN BHD |
| K161320 | EMG Pink Nitrile Examination Glove Powder Free | Sep 01, 2016 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD. |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Aug 04, 2016 | Substantially Equivalent | HARTALEGA SDN BHD |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | Aug 03, 2016 | Substantially Equivalent | KOSSAN INTERNATIONAL SDN. BHD. |
| K160467 | Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | Aug 02, 2016 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | Aug 02, 2016 | Substantially Equivalent | KOSSAN INTERNATIONAL SDN. BHD. |
| K153732 | Powder Free Blue Nitrile Examination Glove | Jul 29, 2016 | Substantially Equivalent | QUBE MEDICAL PRODUCT SDN BHD |
| K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented | Jun 23, 2016 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD. |
| K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | Apr 14, 2016 | Substantially Equivalent | PRIMUS GLOVES PVT LIMITED |
| K152479 | HG Pro Nitrile Powder Free Examination Gloves | Apr 04, 2016 | Substantially Equivalent | HEALTHY GLOVE CO.,LTD |
| K153562 | Powder Free Blue Nitrile Examination Glove | Apr 01, 2016 | Substantially Equivalent | Viet Glove Corporation |
| K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | Mar 31, 2016 | Substantially Equivalent | Halyard Health |
| K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) | Mar 31, 2016 | Substantially Equivalent | HARTALEGA NGC SDN BHD |
| K153510 | Powder Free Polychloroprene Examination Glove Green | Mar 21, 2016 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K152707 | Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color | Mar 17, 2016 | Substantially Equivalent | MINGHAO MEDICAL PRODUCTS CO.,LTD. |
| K152705 | Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color | Mar 17, 2016 | Substantially Equivalent | Jiayuan Medical Products Co., Ltd |
| K152720 | Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color | Mar 10, 2016 | Substantially Equivalent | XINGDA MEDICAL PRODUCTS CO., LTD. |
| K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | Mar 09, 2016 | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. |
| K152715 | HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Feb 25, 2016 | Substantially Equivalent | HAINING MEDICAL PRODUCTS CO., LTD |
| K151680 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Feb 12, 2016 | Substantially Equivalent | SUQIAN XINGYE GLOVE CO, LTD |
| K152271 | Powder Free Nitrile Patient Examination Gloves, Black color | Feb 09, 2016 | Substantially Equivalent | SUQIAN XINGYE GLOVE CO,LTD |
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs | Dec 24, 2015 | Substantially Equivalent | RIVERSTONE RESOURCES SDN BHD |
| K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | Oct 21, 2015 | Substantially Equivalent | HARTALEGA NGC SDN BHD |
| K151528 | Powder Free Nitrile (Black) Examination Gloves | Oct 09, 2015 | Substantially Equivalent | GALLANT QUALITY SDN. BHD. |
| K151684 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) | Sep 18, 2015 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K151208 | Powder Free Nitrile Examination Glove | Sep 14, 2015 | Substantially Equivalent | VRG KHAI HOAN JOINT STOCK COMPANY |
| K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) | Aug 24, 2015 | Substantially Equivalent | HARTALEGA NGC SDN BHD |
| K143289 | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR | Aug 18, 2015 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | Jun 18, 2015 | Substantially Equivalent | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
| K150113 | Fusion Black Powder-Free Nitrile Exam Glove | Jun 18, 2015 | Substantially Equivalent | Halyard Health |
| K150414 | Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL | Jun 12, 2015 | Substantially Equivalent | INDUSTRIAL CLOTHINGS (PVT) LTD |
| K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Jun 09, 2015 | Substantially Equivalent | HARTALEGA SDN BHD |
| K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) | Apr 23, 2015 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | Apr 23, 2015 | Substantially Equivalent | HARTALEGA SDN BHD |
| K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Feb 12, 2015 | Substantially Equivalent | Kossan International Sdn. Bhd. |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla | Feb 12, 2015 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | Feb 11, 2015 | Substantially Equivalent | SIAM SEMPERMED CORP., LTD |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | Feb 09, 2015 | Substantially Equivalent | Careplus (M) SDN BHD |
| K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | Jan 22, 2015 | Substantially Equivalent | CENTRAL MEDICARE SDN BHD |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Jan 16, 2015 | Substantially Equivalent | Careplus (M) SDN BHD |
| K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | Jan 16, 2015 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) | Dec 18, 2014 | Substantially Equivalent | HARTALEGA SDB. BHD. |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | Dec 18, 2014 | Substantially Equivalent | HARTALEGA SDN BHD |
| K141304 | YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Dec 12, 2014 | Substantially Equivalent | YONGXIN HEALTHCARE CO., LTD. |
| K141303 | ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Dec 12, 2014 | Substantially Equivalent | ZHIDA GLOVE CO., LTD. |
| K141287 | HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR | Dec 03, 2014 | Substantially Equivalent | HUIKANG GLOVE CO., LTD. |
| K141279 | WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Dec 03, 2014 | Substantially Equivalent | WANGHUI GLOVE CO., LTD. |
| K141579 | EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE | Oct 17, 2014 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD |
| K141623 | EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM | Oct 07, 2014 | Substantially Equivalent | ECO MEDI GLOVE SDN BHD |
| K141510 | EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | Oct 07, 2014 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD |
| K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE | Sep 12, 2014 | Substantially Equivalent | HARTALEGA SDN BHD |
| K141590 | EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE | Sep 03, 2014 | Substantially Equivalent | ECO MEDI GLOVE SDN. BHD |
| K140418 | POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | Sep 03, 2014 | Substantially Equivalent | WRP RUBBER PRODUCTS SDN BHD |
| K141021 | POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR | Aug 26, 2014 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K133325 | BLUE NITRILE POWDER FREE EXAM GLOVES | Aug 08, 2014 | Substantially Equivalent | SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD. |
| K133168 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | Aug 07, 2014 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | Jul 24, 2014 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K133699 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES | Jul 18, 2014 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K140316 | EXAMINATION GLOVES | Jul 11, 2014 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K140816 | POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | Jul 08, 2014 | Substantially Equivalent | BETTER CARE PLASTIC TECHNOLOGY CO., LTD. |
| K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | Jul 03, 2014 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K132354 | POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE | Jun 30, 2014 | Substantially Equivalent | ADVANCED HEALTH PRODUCTS, LOT 60 & 61 |
| K133193 | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | Jun 23, 2014 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | Jun 20, 2014 | Substantially Equivalent | HARTALEGA NGC SDN. BHD. |
| K133478 | POWDER FREE POLYETHYLENE EXAMINATION GLOVES | Jun 02, 2014 | Substantially Equivalent | SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD |
| K133123 | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F | May 30, 2014 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K133956 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN | May 28, 2014 | Substantially Equivalent | HARTALEGA SDN BHD |
| K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Apr 08, 2014 | Substantially Equivalent | TOP CALIBRE SDN BHD |
| K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | Dec 13, 2013 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K132006 | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) | Nov 07, 2013 | Substantially Equivalent | HARTALEGA SDN BHD |
| K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE | Nov 07, 2013 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | Sep 25, 2013 | Substantially Equivalent | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
| K130846 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN | Aug 08, 2013 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K130473 | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) | Jul 05, 2013 | Substantially Equivalent | HARTALEGA SDN BHD |
| K122464 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE | Apr 12, 2013 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K122453 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY | Apr 05, 2013 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K123749 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE | Mar 01, 2013 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K123869 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | Feb 28, 2013 | Substantially Equivalent | DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD |
| K122727 | BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE | Feb 22, 2013 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K130038 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE | Feb 21, 2013 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K123469 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE | Feb 19, 2013 | Substantially Equivalent | WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II |
| K123116 | CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) | Feb 11, 2013 | Substantially Equivalent | WORLDMED MANUFACTURING SDN. BHD. |
| K123488 | LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE | Feb 08, 2013 | Substantially Equivalent | PUYANG LINSHI HEALTH CO., LTD |
| K122696 | POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) | Jan 31, 2013 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K123760 | MULTIPLE NAME | Jan 28, 2013 | Substantially Equivalent | ASSURGUARD SDN. BHD. |
| K123328 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK | Jan 18, 2013 | Substantially Equivalent | NITRILIST GLOVES MANUFACTURING SDN BHD |
| K121592 | POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | Jan 18, 2013 | Substantially Equivalent | TEKMEDIC (M) SDN BHD |
| K122408 | POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) | Jan 17, 2013 | Substantially Equivalent | HONGYE PLASTIC PRODUCTS CO., LTD. |
| K121549 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE | Dec 27, 2012 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K122874 | POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE | Dec 10, 2012 | Substantially Equivalent | NITRILIST GLOVES MANUFACTURING SDN BHD |
| K122999 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Nov 30, 2012 | Substantially Equivalent | TOP GLOVE SDN. BHD. |
| K120066 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL | Nov 16, 2012 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K122998 | BLUE POWDERED NITRILE EXAMINATION GLOVE | Nov 06, 2012 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K122131 | POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) | Oct 17, 2012 | Substantially Equivalent | MATANG MFG. SDN. BHD. |
| K122465 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK | Oct 16, 2012 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | Oct 16, 2012 | Substantially Equivalent | XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., |
| K120110 | ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET | Oct 04, 2012 | Substantially Equivalent | PROFIT POINT MANUFACTURING SDN BHD |
| K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | Sep 11, 2012 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | Sep 11, 2012 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K122363 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Sep 10, 2012 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K121947 | ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES | Sep 10, 2012 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE | Aug 17, 2012 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K121368 | NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) | Aug 10, 2012 | Substantially Equivalent | MATANG MFG. SDN. BHD. |
| K121526 | POWER-FREE NITRILE PATIENT EXAMINATION GLOVES | Aug 03, 2012 | Substantially Equivalent | SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. |
| K121192 | NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) | Aug 03, 2012 | Substantially Equivalent | TEKMEDIC (M) SDN BHD |
| K120970 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) | Jul 19, 2012 | Substantially Equivalent | TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD |
| K121529 | BLACK NITRILE POWDER-FREE EXAMINATION GLOVES | Jul 12, 2012 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K121464 | BLUE POWER FREE NITRILE EXAMINATION GLOVE | Jul 05, 2012 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K121506 | UTB BLUE POWDER FREE NITRILE | Jul 03, 2012 | Substantially Equivalent | NORTHSTAR HEALTHCARE HOLDINGS |
| K111718 | LANO-E | Jun 08, 2012 | Substantially Equivalent | UG GLOBAL RESOURCES SDN BHD |
| K113440 | HIGH FIVE | May 23, 2012 | Substantially Equivalent | CENTRAL MEDICARE SDN BHD |
| K113639 | C2 MEDICAL GLOVES | May 08, 2012 | Substantially Equivalent | AMERCARE, INC. |
| K120184 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED | May 02, 2012 | Substantially Equivalent | ENCOMPASS MEDICAL SUPPLIES INC LIMITED |
| K112924 | RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME | May 02, 2012 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K111464 | PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES | Apr 19, 2012 | Substantially Equivalent | DIPPED PRODUCTS (THAILAND) LTD |
| K112928 | RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME | Apr 17, 2012 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K112012 | NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES | Mar 21, 2012 | Substantially Equivalent | UG HEALTHCARE (USA), INC. |
| K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | Mar 09, 2012 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K113100 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Feb 06, 2012 | Substantially Equivalent | MAXTER GLOVE MANUFACTURING SDN BHD |
| K112976 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM | Feb 02, 2012 | Substantially Equivalent | HARTALEGA SND. BHD. |
| K111134 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Jan 26, 2012 | Substantially Equivalent | SIEM AEMPEMED CORP., LTD |
| K111248 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) | Dec 01, 2011 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K111772 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE | Oct 20, 2011 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K110979 | DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS | Oct 20, 2011 | Substantially Equivalent | ADVANCED MEDICAL PRODUCTS SDN BHD |
| K103675 | CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE | Oct 03, 2011 | Substantially Equivalent | CHIENMAX VIETNAM CO. LTD |
| K111589 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG | Aug 23, 2011 | Substantially Equivalent | DERMA CARE PLUS PRODUCTS, LLC |
| K103734 | POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE | Aug 19, 2011 | Substantially Equivalent | CENTRAL MEDICARE SDN BHD |
| K111300 | SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) | Aug 12, 2011 | Substantially Equivalent | PT. MAHAKARYA INTI BUANA |
| K110758 | NITRILE POWDER FREE EXAMINATION GLOVES | Aug 12, 2011 | Substantially Equivalent | HARTALEGA SDN BHD |
| K111328 | POWDER FREE NITRILE EXAMINATION GLOVES | Jul 15, 2011 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K110960 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE | Jul 14, 2011 | Substantially Equivalent | KOON SENG SDN.BHD |
| K110418 | POWDER FREE NITRILE EXAMINATION GLOVES | Jul 13, 2011 | Substantially Equivalent | W.A. RUBBERMATE CO., LTD. |
| K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | Jun 15, 2011 | Substantially Equivalent | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
| K110248 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR | Jun 10, 2011 | Substantially Equivalent | JIANGSU DONGLING PLASTIC & RUBBER CO., LTD |
| K110247 | POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | Jun 10, 2011 | Substantially Equivalent | JIANGSU DONGLING PLASTIC & RUBBER CO., LTD |
| K102623 | BLUE POWDERFREE NITRILE EXAMINATION GLOVE | Jun 06, 2011 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K110155 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | May 23, 2011 | Substantially Equivalent | TANGSHAN XIANGRUI PLASTIC PRODUCTS CO., LTD. |
| K110146 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | May 13, 2011 | Substantially Equivalent | TANGSHAN KAIYUE GLOVE CO., LTD. |
| K110102 | POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG | May 13, 2011 | Substantially Equivalent | PREVENTIVE CARE, INC. |
| K103770 | SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL | Apr 21, 2011 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO., LTD |
| K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Apr 15, 2011 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K110185 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | Apr 04, 2011 | Substantially Equivalent | TANGSHAN BAOJIE GLOVE CO., LTD |
| K103670 | NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) | Mar 31, 2011 | Substantially Equivalent | INNOVATIVE GLOVES CO; LTD |
| K103661 | RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE | Mar 23, 2011 | Substantially Equivalent | RUBBERCARE PROTECTION PRODUCTS SDN BHD |
| K102846 | PATIENT EXAMINATION GLOVES | Mar 17, 2011 | Substantially Equivalent | THAI HUA HOLDING CO., LTD. |
| K101820 | NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES | Mar 03, 2011 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K103337 | MULTIPLE NAME | Feb 25, 2011 | Substantially Equivalent | IDEAL QUALITY SDN., BHD. |
| K101870 | SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE | Dec 20, 2010 | Substantially Equivalent | SUNMAX VIETNAM CO. LTD |
| K103249 | NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM | Dec 16, 2010 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K102620 | POWDERFREE BLACK NITRILE EXAMINATION GLOVES | Nov 22, 2010 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K102880 | BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) | Nov 19, 2010 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K101943 | SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES | Nov 08, 2010 | Substantially Equivalent | TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
| K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | Nov 02, 2010 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K101351 | NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT | Oct 15, 2010 | Substantially Equivalent | ASCEND EAGLE, INC. |
| K101594 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | Oct 08, 2010 | Substantially Equivalent | BETTER CARE PLASTIC TECHNOLOGY CP., LTD |
| K101760 | ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES | Oct 06, 2010 | Substantially Equivalent | PROFIT POINT MANUFACTURING SDN BHD |
| K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Oct 04, 2010 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K102230 | NUGARD NITILE GREY COLOR | Sep 10, 2010 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS | Sep 08, 2010 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K101646 | NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR | Sep 08, 2010 | Substantially Equivalent | SGMP CO., LTD. |
| K101630 | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE | Sep 07, 2010 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K100975 | NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE | Aug 17, 2010 | Substantially Equivalent | JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K101595 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | Aug 06, 2010 | Substantially Equivalent | BETTER CARE PLASTIC TECHNOLOGY CP., LTD |
| K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | Jul 16, 2010 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K100979 | NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE | Jul 02, 2010 | Substantially Equivalent | JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K101293 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | Jul 01, 2010 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K093517 | NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE | Jun 29, 2010 | Substantially Equivalent | SUMMIT GLOVE, INC. |
| K093516 | NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES | Jun 29, 2010 | Substantially Equivalent | SUMMIT GLOVE, INC. |
| K092874 | POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES | Jun 22, 2010 | Substantially Equivalent | QUALITY GALLANT SDN. BHD. |
| K093335 | LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) | Jun 18, 2010 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K100369 | POWDER-FREE NITRILE GLOVES, BLACK | May 20, 2010 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K092617 | ROYAL GUARD | May 20, 2010 | Substantially Equivalent | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
| K092472 | NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT | Apr 15, 2010 | Substantially Equivalent | ASCEND EAGLE, INC. |
| K100162 | MULTIPLE PRIVATE LABEL | Mar 24, 2010 | Substantially Equivalent | BIOGREEN YIELDS SDN.BHD |
| K093523 | MICRO-TOUCH NITRILE | Mar 04, 2010 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K093726 | MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Feb 22, 2010 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K093759 | MULTIPLE NAME MODEL MULTIPLE | Feb 19, 2010 | Substantially Equivalent | GX CORPORATION SDN BHD (PLANT 1) |
| K093696 | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 | Feb 12, 2010 | Substantially Equivalent | CENTRAL MEDICARE SDN BHD |
| K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Dec 28, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K092160 | POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES | Nov 27, 2009 | Substantially Equivalent | COMFORT RUBBER GLOVES IND. SDN. BHD. |
| K091965 | POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED | Nov 24, 2009 | Substantially Equivalent | PLATINUM GLOVE INDUSTRIES SDN.BHD. |
| K092498 | LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) | Nov 20, 2009 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | Nov 04, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K092411 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | Oct 21, 2009 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K092034 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK | Oct 19, 2009 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K090568 | MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN | Oct 02, 2009 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K092327 | MICRO-TOUCH NITRA FREE | Sep 21, 2009 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | Sep 16, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | Sep 04, 2009 | Substantially Equivalent | HARTALEGA SDN BHD |
| K090828 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES | Jul 28, 2009 | Substantially Equivalent | ULTRAWIN SDN BHD |
| K091147 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Jul 27, 2009 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | Jul 07, 2009 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K090336 | SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | Jul 01, 2009 | Substantially Equivalent | SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
| K091151 | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN | Jun 01, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K090412 | POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). | Jun 01, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K082957 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS | May 29, 2009 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K083156 | NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | May 08, 2009 | Substantially Equivalent | GIGA-DRIVE SDN, BHD |
| K090464 | BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE | Apr 23, 2009 | Substantially Equivalent | PT MAHAKARYA INTI BUANA |
| K081970 | BIOCLEAN CHEMO SHIELD | Mar 11, 2009 | Substantially Equivalent | NITRITEX (M) SDN. BHD. |
| K083908 | BLACK NITRILE EXAMINATION GLOVES | Mar 06, 2009 | Substantially Equivalent | INNOVATIVE GLOVES CO; LTD |
| K083755 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS | Mar 05, 2009 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K083624 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | Feb 10, 2009 | Substantially Equivalent | COMFORT RUBBER GLOVES IND. SDN. BHD. |
| K082428 | N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE | Feb 10, 2009 | Substantially Equivalent | BEST GLOVE, INC |
| K083717 | POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK | Jan 30, 2009 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K081911 | NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE | Jan 15, 2009 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K082598 | POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE | Jan 07, 2009 | Substantially Equivalent | TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. |
| K081972 | BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES | Dec 11, 2008 | Substantially Equivalent | NITRITEX (M) SDN. BHD. |
| K082302 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM | Dec 09, 2008 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | Dec 03, 2008 | Substantially Equivalent | QUALITY GALLANT SDN. BHD. |
| K082125 | N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT | Nov 21, 2008 | Substantially Equivalent | BEST GLOVE, INC |
| K082457 | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | Nov 10, 2008 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Oct 17, 2008 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K081594 | MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE | Oct 17, 2008 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | Sep 12, 2008 | Substantially Equivalent | DYNAREX CORPORATION |
| K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | Aug 11, 2008 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K081466 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Jul 30, 2008 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | Jul 09, 2008 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K081027 | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) | Jun 30, 2008 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K080536 | MICRO-TOUCH NITRAFREE | Jun 19, 2008 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | May 23, 2008 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K080165 | SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) | May 14, 2008 | Substantially Equivalent | PLATINUM GLOVE INDUSTRIES SDN.BHD. |
| K080520 | NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM | Apr 30, 2008 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K072400 | NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES | Mar 27, 2008 | Substantially Equivalent | SGMP CO., LTD. |
| K080066 | VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) | Mar 05, 2008 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | Oct 04, 2007 | Substantially Equivalent | MEDTEXX MANUFACTURING SDN. BHD. |
| K071170 | POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL | Sep 14, 2007 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) | Sep 06, 2007 | Substantially Equivalent | HARTALEGA SDN BHD |
| K071072 | SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | Aug 30, 2007 | Substantially Equivalent | SHANGHAI CHINA STAR CORP |
| K071207 | MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES | Aug 07, 2007 | Substantially Equivalent | HIGH MOMENTUM SDN BHD |
| K071208 | MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES | Jul 30, 2007 | Substantially Equivalent | HIGH MOMENTUM SDN BHD |
| K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | Jul 24, 2007 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K070639 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING | Jun 15, 2007 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K070862 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) | May 30, 2007 | Substantially Equivalent | PURTECH CLEANROOM PRODUCTS CO., LTD. |
| K070861 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | May 15, 2007 | Substantially Equivalent | HONG XIN RUBBER PRODUCTS CO., LTD |
| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | Apr 19, 2007 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K061505 | POWERED NITRILE BLUE EXAMINATION GLOVES | Apr 09, 2007 | Substantially Equivalent | LIWE TRADING |
| K070404 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | Mar 26, 2007 | Substantially Equivalent | TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
| K070097 | POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | Mar 23, 2007 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | Mar 20, 2007 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) | Mar 20, 2007 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K061504 | POWDER FREE NITRILE BLUE EXAMINATION GLOVE | Mar 19, 2007 | Substantially Equivalent | LIWE TRADING |
| K070096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR | Mar 14, 2007 | Substantially Equivalent | GX CORPORATION SDN BHD |
| K063777 | ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE | Feb 23, 2007 | Substantially Equivalent | BRIGHT ELEMENT SDN BHD |
| K063522 | POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) | Feb 08, 2007 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) | Jan 23, 2007 | Substantially Equivalent | HL RUBBER INDUSTRIES SDN BHD |
| K063046 | NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) | Nov 17, 2006 | Substantially Equivalent | HARTALEGA SDN BHD |
| K062778 | STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | Oct 27, 2006 | Substantially Equivalent | WEAR SAFE MALAYSIA SDN. BHD. |
| K062138 | POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE | Oct 05, 2006 | Substantially Equivalent | MOLNLYCKE HEALTH CARE, INC. |
| K062067 | TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR | Sep 06, 2006 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K061724 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) | Jul 25, 2006 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K061553 | NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES | Jul 17, 2006 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K052583 | BLUE POWDER FREE NITRILE EXAMINATION GLOVES | Jun 14, 2006 | Substantially Equivalent | HARTALEGA SDN BHD |
| K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | Jun 09, 2006 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K060726 | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) | May 25, 2006 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K061074 | ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES | May 24, 2006 | Substantially Equivalent | BRIGHT ELEMENT SDN BHD |
| K061192 | BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES | May 23, 2006 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K060724 | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) | May 17, 2006 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED | May 01, 2006 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
| K060073 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING | May 01, 2006 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K060147 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Apr 28, 2006 | Substantially Equivalent | HONGYE PLASTIC PRODUCTS CO., LTD. |
| K060753 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) | Apr 27, 2006 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K060733 | SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 | Apr 24, 2006 | Substantially Equivalent | BARRIERMED, INC. |
| K053366 | NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE | Mar 30, 2006 | Substantially Equivalent | PT. MAHAKARYA INTI BUANA |
| K053657 | POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | Feb 13, 2006 | Substantially Equivalent | PT. MAHAKARYA INTI BUANA |
| K052955 | NITRILE BLUE POWDERED EXAMINATION GLOVES | Jan 19, 2006 | Substantially Equivalent | GREAT GLOVE SDN BHD |
| K052956 | NITRILE BLUE POWDER FREE EXAMINATION GLOVE | Dec 21, 2005 | Substantially Equivalent | GREAT GLOVE SDN BHD |
| K052892 | SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 | Nov 30, 2005 | Substantially Equivalent | BARRIERMED GLOVE CO. |
| K052502 | NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES | Nov 18, 2005 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K052877 | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE | Nov 08, 2005 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K052890 | NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E | Oct 31, 2005 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K052382 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Sep 15, 2005 | Substantially Equivalent | PT. SHAMROCK MANUFACTURING CORP. |
| K051777 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) | Aug 12, 2005 | Substantially Equivalent | HARTALEGA SDN BHD |
| K051378 | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Aug 03, 2005 | Substantially Equivalent | MEDLINE |
| K051778 | NITRILE POWDERED EXAMINATION GLOVES (BLUE) | Jul 26, 2005 | Substantially Equivalent | HARTALEGA SDN BHD |
| K051662 | VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) | Jul 22, 2005 | Substantially Equivalent | GRAND WORK PLASTIC PRODUCTS CO., LTD. |
| K051333 | NITRILE EXAMINATION GLOVES, POWDER FREE | Jul 22, 2005 | Substantially Equivalent | SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. |
| K050968 | POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES | Jul 12, 2005 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K051372 | POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) | Jul 07, 2005 | Substantially Equivalent | PLATINUM GLOVE INDUSTRIES SDN.BHD. |
| K051317 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR | Jun 20, 2005 | Substantially Equivalent | PLATINUM GLOVE INDUSTRIES SDN.BHD. |
| K051318 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) | Jun 17, 2005 | Substantially Equivalent | PLATINUM GLOVE INDUSTRIES SDN.BHD. |
| K051347 | KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE | Jun 07, 2005 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K043149 | FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) | May 25, 2005 | Substantially Equivalent | FIRSTLINE, LLC. |
| K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) | May 19, 2005 | Substantially Equivalent | SPI GLOVES SDN. BHD. |
| K050122 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) | Apr 18, 2005 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K050765 | LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE | Apr 08, 2005 | Substantially Equivalent | N.S. UNI-GLOVES SDN. BHD. |
| K050598 | POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) | Apr 07, 2005 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K050467 | POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN | Mar 30, 2005 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K050531 | POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) | Mar 18, 2005 | Substantially Equivalent | SPI GLOVES SDN. BHD. |
| K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) | Mar 16, 2005 | Substantially Equivalent | SPI GLOVES SDN. BHD. |
| K050214 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) | Mar 16, 2005 | Substantially Equivalent | HARTALEGA SDN BHD |
| K050215 | NITRILE POWDERED EXAMINATION GLOVES (WHITE) | Mar 11, 2005 | Substantially Equivalent | HARTALEGA SDN BHD |
| K042898 | PANTHERA N POWDER FREE BLACK NITRILE GLOVES | Jan 18, 2005 | Substantially Equivalent | GLOVCO (M) SDN. BHD. |
| K042879 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING | Jan 13, 2005 | Substantially Equivalent | SGMP CO., LTD. |
| K042239 | FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE | Dec 16, 2004 | Substantially Equivalent | PT. MANDIRI INTI BUANA |
| K042817 | MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | Dec 06, 2004 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K041913 | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE | Dec 01, 2004 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | Sep 30, 2004 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K042378 | NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | Sep 20, 2004 | Substantially Equivalent | SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD. |
| K042238 | CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES | Sep 16, 2004 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K042101 | CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES | Aug 27, 2004 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K041848 | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR | Aug 20, 2004 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K041276 | POWDER-FREE NITRILE EXAMINATION GLOVES | Aug 20, 2004 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K041391 | FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | Jul 09, 2004 | Substantially Equivalent | HARTALEGA SDN BHD |
| K040841 | POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Jul 08, 2004 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K040791 | POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Jun 03, 2004 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | Apr 22, 2004 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K034052 | BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | Mar 15, 2004 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K033887 | NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES | Mar 02, 2004 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K033086 | NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE | Feb 26, 2004 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K040176 | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES | Feb 24, 2004 | Substantially Equivalent | MAXTER GLOVE MANUFACTURING SDN BHD |
| K033777 | ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | Feb 05, 2004 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K033683 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR | Jan 08, 2004 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K032024 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Oct 29, 2003 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K031944 | VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR | Sep 23, 2003 | Substantially Equivalent | ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K032549 | MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | Sep 08, 2003 | Substantially Equivalent | MATANG MFG. SDN. BHD. |
| K032077 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) | Aug 19, 2003 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K032011 | GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE | Aug 19, 2003 | Substantially Equivalent | PT. WRP BUANA MULTICORPORA |
| K032010 | GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE | Aug 19, 2003 | Substantially Equivalent | PT. WRP BUANA MULTICORPORA |
| K031157 | POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED | Aug 15, 2003 | Substantially Equivalent | QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
| K030529 | LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE | Aug 08, 2003 | Substantially Equivalent | JDA (TIANJIN) PLASTIC RUBBER CO., LTD. |
| K031768 | BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED | Aug 01, 2003 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K031625 | POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED | Aug 01, 2003 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K031580 | NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE | Jul 25, 2003 | Substantially Equivalent | GREEN PROSPECT SDN BHD |
| K031591 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED | Jun 26, 2003 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K031384 | MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G | Jun 17, 2003 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 | May 02, 2003 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K030245 | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR | Apr 04, 2003 | Substantially Equivalent | ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K030386 | POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE | Mar 28, 2003 | Substantially Equivalent | SHAMROCK MANUFACTURING COMPANY |
| K030284 | POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) | Mar 25, 2003 | Substantially Equivalent | PT. SMARTGLOVE INDONESIA |
| K030075 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) | Mar 05, 2003 | Substantially Equivalent | BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER |
| K030335 | ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED | Mar 03, 2003 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K030406 | NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR | Feb 27, 2003 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K022814 | MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) | Feb 19, 2003 | Substantially Equivalent | PT. SMART GLOVE INDONESIA |
| K023072 | POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR | Feb 13, 2003 | Substantially Equivalent | ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K023979 | NITRILE EXAMINATION GLOVES, PRE-POWDERED | Jan 24, 2003 | Substantially Equivalent | STARMATRIX SDN BHD |
| K023978 | NITRILE EXAMINATION GLOVES, POWDER FREE | Jan 24, 2003 | Substantially Equivalent | STARMATRIX SDN BHD |
| K024184 | POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED | Jan 14, 2003 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K024083 | GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | Jan 10, 2003 | Substantially Equivalent | SUPERMAX GLOVE MANUFACTURING SDN BHD |
| K024025 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR | Dec 18, 2002 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
| K023702 | POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE | Dec 18, 2002 | Substantially Equivalent | NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. |
| K023517 | DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE | Dec 02, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K022671 | FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES | Nov 18, 2002 | Substantially Equivalent | HARTALEGA SDN BHD |
| K022784 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR | Nov 13, 2002 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K022572 | NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES | Nov 08, 2002 | Substantially Equivalent | AR ALLIANCE HEALTHCARE SDN. BHD. |
| K023428 | VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE | Oct 25, 2002 | Substantially Equivalent | SHANGHAI JIAWANG INDUSTRIAL CO. LTD. |
| K022346 | CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES | Oct 18, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 11, 2002 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 09, 2002 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K022781 | MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | Oct 08, 2002 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | Oct 03, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K022878 | BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) | Sep 17, 2002 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K022818 | MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | Sep 17, 2002 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K022619 | POWDER FREE NITRILE EXAMINATION GLOVES | Sep 06, 2002 | Substantially Equivalent | AR ALLIANCE HEALTHCARE SDN. BHD. |
| K022090 | SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE | Sep 03, 2002 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K022102 | CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR | Aug 22, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K022548 | MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | Aug 15, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K022347 | MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES | Aug 15, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K021668 | NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) | Aug 12, 2002 | Substantially Equivalent | INNOVATIVE GLOVES CO; LTD |
| K022095 | DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE | Aug 09, 2002 | Substantially Equivalent | WILSHIRE TECHNOLOGIES |
| K022101 | MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR | Aug 02, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K022024 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) | Aug 01, 2002 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K021452 | STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE | Aug 01, 2002 | Substantially Equivalent | MAXXIM MEDICAL |
| K021730 | GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) | Jul 05, 2002 | Substantially Equivalent | GLOVCO (M) SDN. BHD. |
| K021743 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW | Jun 10, 2002 | Substantially Equivalent | COPIOUMED INTL., INC. |
| K021506 | POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES | Jun 06, 2002 | Substantially Equivalent | SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
| K021220 | NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Jun 06, 2002 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K021000 | SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES | May 31, 2002 | Substantially Equivalent | SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
| K021013 | SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) | May 22, 2002 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K021396 | DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE | May 16, 2002 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K021001 | SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES | May 16, 2002 | Substantially Equivalent | SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
| K021308 | GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES | May 14, 2002 | Substantially Equivalent | GLOVCO (M) SDN. BHD. |
| K020751 | SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE | May 02, 2002 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K020868 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) | Apr 22, 2002 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K013774 | CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA | Mar 05, 2002 | Substantially Equivalent | SUPERMAX SDN BHD |
| K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | Feb 26, 2002 | Substantially Equivalent | SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
| K014284 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE | Feb 15, 2002 | Substantially Equivalent | FORMOSA GLOVE INDUSTRIAL CO., LTD. |
| K020317 | NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE | Feb 14, 2002 | Substantially Equivalent | SGMP CO., LTD. |
| K014285 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE | Feb 14, 2002 | Substantially Equivalent | FORMOSA GLOVE INDUSTRIAL CO., LTD. |
| K013998 | POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES | Feb 13, 2002 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K014077 | POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES | Feb 04, 2002 | Substantially Equivalent | SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
| K013254 | POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | Feb 04, 2002 | Substantially Equivalent | TOP QUALITY MFG., INC. |
| K013303 | CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER | Jan 23, 2002 | Substantially Equivalent | LATEXX MANUFACTURING SDN.BHD. |
| K013261 | MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE | Nov 29, 2001 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K012853 | SMART GLOVE STERILE NITRILE EXAM GLOVE | Nov 16, 2001 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K013016 | TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE | Oct 19, 2001 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K012786 | POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) | Oct 01, 2001 | Substantially Equivalent | SHAMROCK MANUFACTURING COMPANY |
| K011961 | POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 | Sep 26, 2001 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K010232 | PRE-POWDERED NITRILE EXAMINATION GLOVES | Sep 21, 2001 | Substantially Equivalent | P.T. HEALTHCARE GLOVINDO |
| K012899 | GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE | Sep 18, 2001 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K011613 | POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE | Sep 17, 2001 | Substantially Equivalent | SHIELD GLOVES MANUFACTURER (M) SDN BHD |
| K012048 | POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE | Aug 16, 2001 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K011765 | SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE | Aug 16, 2001 | Substantially Equivalent | SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
| K011717 | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES | Aug 14, 2001 | Substantially Equivalent | SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
| K012166 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) | Aug 01, 2001 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K011792 | NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | Aug 01, 2001 | Substantially Equivalent | LATEXX PARTNERS BHD. |
| K011791 | POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR | Aug 01, 2001 | Substantially Equivalent | LATEXX PARTNERS BHD. |
| K011924 | POWDERED BLUE NITRILE EXAMINATION GLOVES | Jul 10, 2001 | Substantially Equivalent | SELTOM PACIFIC SDN. BHD. |
| K011497 | CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE | Jul 10, 2001 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K011482 | DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Jul 09, 2001 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K011713 | SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE | Jul 05, 2001 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K010233 | POWDER FREE NITRILE EXAMINATION GLOVES | Jun 22, 2001 | Substantially Equivalent | P.T. HEALTHCARE GLOVINDO |
| K011593 | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | Jun 21, 2001 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K011198 | SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL | May 17, 2001 | Substantially Equivalent | MAXXIM MEDICAL, INC. |
| K011286 | POWDER-FREE NITRILE EXAM GLOVE, BLUE | May 16, 2001 | Substantially Equivalent | NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. |
| K010863 | LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) | May 03, 2001 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K011012 | POWDER FREE NITRILE EXAMINATION GLOVE | May 01, 2001 | Substantially Equivalent | CONTRACT LATEX DIPPERS SDN BHD |
| K010719 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR | Apr 10, 2001 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K010486 | POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | Apr 10, 2001 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K010861 | LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) | Apr 03, 2001 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K010860 | LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) | Apr 03, 2001 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K010110 | POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE | Apr 03, 2001 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Mar 30, 2001 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K010077 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES | Feb 28, 2001 | Substantially Equivalent | PWA INDUSTRIES SDN. BHD. |
| K010297 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) | Feb 16, 2001 | Substantially Equivalent | MAXXIM MEDICAL |
| K003922 | NITRILE EXAMINATION GLOVES (POWERED) | Feb 15, 2001 | Substantially Equivalent | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
| K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | Feb 09, 2001 | Substantially Equivalent | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
| K010247 | SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES | Feb 06, 2001 | Substantially Equivalent | SHANGHAI CHINASTAR CORP. |
| K010072 | POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE | Jan 26, 2001 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K003675 | SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES | Jan 09, 2001 | Substantially Equivalent | SHANGHAI CHINASTAR CORP. |
| K003563 | POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE | Jan 02, 2001 | Substantially Equivalent | NING BO YUJIANG RUBBER & PLASTIC CO. |
| K002391 | NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) | Dec 04, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K002819 | NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE | Nov 29, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K002818 | NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE | Nov 29, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K002064 | COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL | Nov 28, 2000 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K003353 | MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA | Nov 22, 2000 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K001613 | COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Nov 22, 2000 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K003233 | RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE | Nov 03, 2000 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K003232 | RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) | Oct 26, 2000 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K994281 | BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) | Oct 20, 2000 | Substantially Equivalent | BIOPRO (M) SDN BHD |
| K994276 | BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) | Oct 20, 2000 | Substantially Equivalent | BIOPRO (M) SDN BHD |
| K000145 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE | Sep 13, 2000 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K000143 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED | Sep 13, 2000 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K000139 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED | Sep 13, 2000 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K000138 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE | Sep 13, 2000 | Substantially Equivalent | INDUSTRIAL CLOTHINGS, LTD. |
| K002220 | NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE | Aug 15, 2000 | Substantially Equivalent | SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
| K002218 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE | Aug 15, 2000 | Substantially Equivalent | SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
| K994124 | NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES | Aug 11, 2000 | Substantially Equivalent | MAPA PROFESSIONAL |
| K002217 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE | Aug 11, 2000 | Substantially Equivalent | SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
| K002216 | NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE | Aug 11, 2000 | Substantially Equivalent | SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
| K001836 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE | Jul 26, 2000 | Substantially Equivalent | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
| K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | Jul 26, 2000 | Substantially Equivalent | MULTISAFE SDN BHD |
| K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | Jul 26, 2000 | Substantially Equivalent | MULTISAFE SDN BHD |
| K001375 | ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Jul 25, 2000 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K001837 | NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE | Jul 11, 2000 | Substantially Equivalent | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
| K001637 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR | Jun 23, 2000 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K001549 | MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) | Jun 12, 2000 | Substantially Equivalent | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
| K000813 | FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM | Jun 08, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE COPORATION |
| K001155 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR | May 23, 2000 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K001128 | NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE | May 23, 2000 | Substantially Equivalent | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
| K001065 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR | May 23, 2000 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | May 03, 2000 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K000689 | UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES | Apr 28, 2000 | Substantially Equivalent | N.S. UNI-GLOVES SDN. BHD. |
| K000868 | NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES | Apr 20, 2000 | Substantially Equivalent | SGMP CO., LTD. |
| K000223 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | Apr 14, 2000 | Substantially Equivalent | PHOENIX MEDICAL TECHNOLOGY, INC. |
| K000688 | UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES | Apr 12, 2000 | Substantially Equivalent | N.S. UNI-GLOVES SDN. BHD. |
| K000670 | NITRILE EXAM GLOVE, POWDER FREE, BLUE | Apr 12, 2000 | Substantially Equivalent | SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. |
| K000330 | NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE | Apr 05, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K000329 | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE | Apr 05, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K000323 | NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE | Apr 05, 2000 | Substantially Equivalent | SIAM SEMPERMED CORP. LTD. |
| K993805 | NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) | Mar 10, 2000 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K000226 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR | Mar 02, 2000 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | Feb 07, 2000 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K994246 | OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | Jan 31, 2000 | Substantially Equivalent | OMNIGRACE LTD. |
| K994064 | BLUE NITRILE EXAMINATION GLOVES - POWDER FREE | Jan 28, 2000 | Substantially Equivalent | GLOVE SOURCE, INC. |
| K992675 | PATIENT NITRILE EXAMINATION GLOVES (POWDERED) | Jan 20, 2000 | Substantially Equivalent | WEAR SAFE MALAYSIA SDN. BHD. |
| K993127 | MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) | Dec 02, 1999 | Substantially Equivalent | GLOVESWORLD INDUSTRIES SDN. BHD. |
| K993313 | COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE | Nov 23, 1999 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K993348 | NIL, NITRILE EXAMINATION GLOVE - POWDER FREE | Nov 19, 1999 | Substantially Equivalent | SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
| K993347 | NIL, NITRILE EXAMINATION GLOVE - POWDERED | Nov 19, 1999 | Substantially Equivalent | SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
| K993311 | COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE | Nov 19, 1999 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | Nov 17, 1999 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K993133 | CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN | Nov 17, 1999 | Substantially Equivalent | SEAL POLYMER INDUSTRIES BHD. |
| K992678 | PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED | Nov 17, 1999 | Substantially Equivalent | WEAR SAFE MALAYSIA SDN. BHD. |
| K993050 | OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | Nov 09, 1999 | Substantially Equivalent | OMNIGRACE LTD. |
| K993325 | INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE | Nov 05, 1999 | Substantially Equivalent | INNOVATIVE GLOVES CO; LTD |
| K993247 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | Nov 05, 1999 | Substantially Equivalent | JDA INTL., INC. |
| K992924 | QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED | Nov 05, 1999 | Substantially Equivalent | LATEXX PARTNERS BHD. |
| K992841 | TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES | Oct 29, 1999 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K993258 | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES | Oct 27, 1999 | Substantially Equivalent | SUPERMAX SDN BHD |
| K992830 | SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE | Oct 27, 1999 | Substantially Equivalent | SAFESKIN CORP. |
| K990752 | DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE | Oct 18, 1999 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K990750 | DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE | Oct 15, 1999 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K992768 | NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent | ANSELL PERRY |
| K992360 | TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES | Oct 12, 1999 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K992558 | NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE | Sep 27, 1999 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K992686 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR | Sep 24, 1999 | Substantially Equivalent | SHEEN MORE ENT. CO., LTD. |
| K992671 | QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES | Sep 24, 1999 | Substantially Equivalent | LATEXX PARTNERS BHD. |
| K992588 | BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | Sep 10, 1999 | Substantially Equivalent | FORMOSA GLOVE INDUSTRIAL CO., LTD. |
| K992210 | SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES | Sep 10, 1999 | Substantially Equivalent | SAFESKIN CORP. |
| K992170 | N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Sep 07, 1999 | Substantially Equivalent | BEST MANUFACTURING COMPANY |
| K992223 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE | Aug 30, 1999 | Substantially Equivalent | PAMITEX INDUSTRIES SDN BHD |
| K992497 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Aug 25, 1999 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
| K992496 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Aug 25, 1999 | Substantially Equivalent | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
| K992062 | SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES | Aug 25, 1999 | Substantially Equivalent | SAFESKIN CORP. |
| K992299 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE | Aug 23, 1999 | Substantially Equivalent | PAMITEX INDUSTRIES SDN BHD |
| K991779 | NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) | Aug 11, 1999 | Substantially Equivalent | SELTOM PACIFIC SDN. BHD. |
| K991776 | NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) | Aug 11, 1999 | Substantially Equivalent | SELTOM PACIFIC SDN. BHD. |
| K990883 | LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) | Aug 10, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K991981 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR | Aug 05, 1999 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K991846 | PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE | Aug 05, 1999 | Substantially Equivalent | OMNIGRACE LTD. |
| K991845 | PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. | Aug 05, 1999 | Substantially Equivalent | OMNIGRACE LTD. |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent | MAXXIM MEDICAL |
| K992177 | NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE | Jul 29, 1999 | Substantially Equivalent | PT. BERLIAN GLOVINDO |
| K991821 | NITRILE EXAMINATION GLOVE, POWDERED, BLUE | Jul 01, 1999 | Substantially Equivalent | NING BO YUJIANG RUBBER & PLASTIC CO. |
| K991744 | SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT | Jun 23, 1999 | Substantially Equivalent | SHIELD GLOVES MANUFACTURER (M) SDN BHD |
| K991304 | HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Jun 23, 1999 | Substantially Equivalent | M.R.G. INDUSTRIES SDN. BHD. |
| K990876 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) | Jun 23, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K990186 | SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | Jun 21, 1999 | Substantially Equivalent | SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD |
| K991511 | POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) | Jun 03, 1999 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K990668 | POWDER FREE BLUE NITRILE GLOVE | Jun 03, 1999 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K991640 | HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES | May 28, 1999 | Substantially Equivalent | M.R.G. INDUSTRIES BERHAD |
| K991493 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | May 26, 1999 | Substantially Equivalent | MASJU SDN. BHD. |
| K990963 | RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) | May 26, 1999 | Substantially Equivalent | RIVERSTONE RESOURCES SDN. BHD. |
| K990882 | LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) | May 21, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K990878 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) | May 21, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K990841 | NUGARD NITRIL NITRILE EXAMINATION GLOVE | May 17, 1999 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K990840 | NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE | May 17, 1999 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K990698 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE | May 13, 1999 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K990696 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE | May 13, 1999 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K990701 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE | May 05, 1999 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K990695 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE | May 04, 1999 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K990577 | TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES | May 04, 1999 | Substantially Equivalent | TA CHIA RUBBER IND. CORP. |
| K990575 | TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES | May 04, 1999 | Substantially Equivalent | TA CHIA RUBBER IND. CORP. |
| K984249 | SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE | May 04, 1999 | Substantially Equivalent | LONDON INTERNATIONAL GROUP, INC. |
| K990486 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. | Apr 23, 1999 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K990485 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR | Apr 23, 1999 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K990427 | ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE | Apr 23, 1999 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K990542 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | Apr 09, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K990541 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) | Apr 09, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K990499 | PREPOWDERED NITRILE EXAMINATION GLOVES | Apr 02, 1999 | Substantially Equivalent | FLEXITECH SDN. BHD. |
| K990495 | POWDER FREE NITRILE EXAMINATION GLOVES | Apr 02, 1999 | Substantially Equivalent | FLEXITECH SDN. BHD. |
| K990420 | LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) | Mar 29, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K990415 | LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) | Mar 29, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K990299 | POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES | Mar 29, 1999 | Substantially Equivalent | SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
| K990267 | POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES | Mar 29, 1999 | Substantially Equivalent | SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
| K990013 | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES | Mar 23, 1999 | Substantially Equivalent | YTY INDUSTRY (MANJUNG) SDN. BHD. |
| K990453 | NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | Mar 09, 1999 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K990283 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | Mar 09, 1999 | Substantially Equivalent | HARTALEGA SDN BHD |
| K983334 | NITRILE POWDER FREE EXAMINATION GLOVES | Feb 19, 1999 | Substantially Equivalent | CRANBERRY (M) SDN. BHD. |
| K984615 | POWDERED NITRILE EXAMINATION GLOVES | Feb 17, 1999 | Substantially Equivalent | SHIVA MEDICARE LTD. |
| K984309 | NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED | Feb 12, 1999 | Substantially Equivalent | SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. |
| K984610 | POWDER FREE NITRILE EXAMINATION GLOVES | Feb 09, 1999 | Substantially Equivalent | SHIVA MEDICARE LTD. |
| K984311 | NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE | Feb 09, 1999 | Substantially Equivalent | SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. |
| K984605 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) | Jan 25, 1999 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K983828 | NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE | Jan 21, 1999 | Substantially Equivalent | SINETIMED LATEX SDN BHD |
| K984356 | NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) | Jan 08, 1999 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K983730 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE | Dec 11, 1998 | Substantially Equivalent | OMNIGRACE LTD. |
| K983729 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE | Dec 11, 1998 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K983725 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE | Dec 07, 1998 | Substantially Equivalent | OMNIGRACE LTD. |
| K983146 | ARSOFT | Dec 07, 1998 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K983825 | NITRILE LATEX POWDER FREE EXAMINATION GLOVE | Dec 04, 1998 | Substantially Equivalent | TOP GLOVE SDN. BHD. |
| K983816 | NITRILE LATEX POWDERED EXAMINATION GLOVE | Dec 04, 1998 | Substantially Equivalent | TOP GLOVE SDN. BHD. |
| K982218 | NITRILE POWDER-FREE UNISEAL GLOVES | Nov 30, 1998 | Substantially Equivalent | AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
| K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | Nov 05, 1998 | Substantially Equivalent | PT. IRAMA DINAMIKA LATEX |
| K982131 | NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Oct 29, 1998 | Substantially Equivalent | ANSELL EDMONT INDUSTRIAL, INC. |
| K982440 | NITRILE PATIENT EXAMINATION GLOVE | Sep 30, 1998 | Substantially Equivalent | PERUSAHAAN GETAH ASAS SDN BHD |
| K982274 | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE | Aug 11, 1998 | Substantially Equivalent | ASIA PACIFIC LATEX SDN BHD |
| K981879 | POWDERED NITRILE EXAMINATION GLOVES | Aug 11, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K981878 | POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) | Aug 11, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K981877 | NITRILE POWDERFREE EXAMINATION GLOVES | Aug 11, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K981675 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | Jul 28, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K981674 | POWDERED GREEN NITRILE EXAMINATION GLOVES | Jul 28, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K981673 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | Jul 28, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K980966 | SUPERGLOVES POWDERED NITRILE | Jul 22, 1998 | Substantially Equivalent | SUPERMAX SDN BHD |
| K981333 | NITRILON CORRECT-TOUCH | Jun 22, 1998 | Substantially Equivalent | BIOPRO (M) SDN BHD |
| K981304 | NITRILON CORRECT-TOUCH | Jun 22, 1998 | Substantially Equivalent | CT INTL. |
| K981133 | POWDERED NITRILE EXAMINATION GLOVES | Jun 05, 1998 | Substantially Equivalent | SERVICOM SERVICES SDN BHD |
| K981159 | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES | Jun 01, 1998 | Substantially Equivalent | LATEXX PARTNERS BHD. |
| K981349 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES | May 18, 1998 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K981179 | LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES | May 15, 1998 | Substantially Equivalent | LOVYTEX SDN BHD |
| K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | Apr 21, 1998 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K980589 | AR SAFE NITRILE EXAMINATION GLOVES | Apr 14, 1998 | Substantially Equivalent | ALLIANCE RUBBER PRODUCTS SDN. BHD. |
| K980807 | NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE) | Apr 02, 1998 | Substantially Equivalent | PT. EKA WIRA ASIA |
| K980729 | NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) | Apr 02, 1998 | Substantially Equivalent | PT. EKA WIRA ASIA |
| K980802 | NITRILE EXAM GLOVE, POWDER-FREE, BLUE | Mar 25, 1998 | Substantially Equivalent | TUCKER & ASSOCIATES |
| K980677 | NITRILE EXAM GLOVE, POWDER FREE | Mar 16, 1998 | Substantially Equivalent | NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. |
| K980511 | NITRILE EXAMINATION GLOVES - POWDER FREE | Mar 13, 1998 | Substantially Equivalent | INFLUX PACIFIC SDN. BHD. |
| K980421 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED | Mar 13, 1998 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K980419 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE | Mar 13, 1998 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K980285 | POWDERFREE BLUE NITRILE EXAMINATION GLOVES | Mar 13, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K980280 | POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Mar 13, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K980275 | POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) | Mar 13, 1998 | Substantially Equivalent | BESGLOVE MEDICARE SDN. BHD. |
| K974907 | NITRILE PRE-POWDERED EXAMINATION GLOVES | Mar 13, 1998 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K974710 | NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE | Feb 25, 1998 | Substantially Equivalent | SINOCHEM NINGBO LATEX GLOVES FACTORY |
| K980150 | POWDER-FREE NITRILE EXAMINATION GLOVES | Feb 09, 1998 | Substantially Equivalent | MASJU SDN. BHD. |
| K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES | Jan 30, 1998 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K980149 | POWDERED NITRILE EXAMINATION GLOVES | Jan 29, 1998 | Substantially Equivalent | MASJU SDN. BHD. |
| K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | Jan 29, 1998 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K974223 | NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES | Dec 18, 1997 | Substantially Equivalent | DERLIN COMPANY LTD. |
| K974185 | POLYMER NITRILE EXAMINATION GLOVES | Dec 18, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K974183 | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Dec 18, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K974114 | DASH, VITAL GARD | Dec 18, 1997 | Substantially Equivalent | DASH MEDICAL GLOVES SDN BHD |
| K974182 | POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Dec 17, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K973903 | POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Dec 17, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K973059 | PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | Nov 07, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K973058 | PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) | Nov 07, 1997 | Substantially Equivalent | SRI JOHANI SDN. BHD. |
| K973551 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Nov 06, 1997 | Substantially Equivalent | PWA INDUSTRIES SDN. BHD. |
| K972090 | POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES | Nov 05, 1997 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K972757 | ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE | Oct 29, 1997 | Substantially Equivalent | SHIELD GLOVES MANUFACTURER (M) SDN BHD |
| K972169 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Oct 03, 1997 | Substantially Equivalent | PWA INDUSTRIES SDN. BHD. |
| K970216 | NITRILE EXAMINATION GLOVES-PRE POWDERED | Sep 26, 1997 | Substantially Equivalent | INFLUX PACIFIC SDN. BHD. |
| K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | Sep 12, 1997 | Substantially Equivalent | PT. IRAMA DINAMIKA LATEX |
| K971356 | POWDER FREE SYNTHETIC EXAMINATION GLOVES | Sep 05, 1997 | Substantially Equivalent | ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K972838 | POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) | Aug 15, 1997 | Substantially Equivalent | ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
| K972195 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Jul 29, 1997 | Substantially Equivalent | ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
| K972177 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Jul 29, 1997 | Substantially Equivalent | ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
| K971666 | SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES | Jul 03, 1997 | Substantially Equivalent | SJ MEDICAL PRODUCTS (M) SDN BHD |
| K971665 | SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES | Jun 27, 1997 | Substantially Equivalent | SJ MEDICAL PRODUCTS (M) SDN BHD |
| K970015 | ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES | Jun 24, 1997 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K965095 | NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Apr 22, 1997 | Substantially Equivalent | ANSELL EDMONT INDUSTRIAL, INC. |
| K964628 | NITRILE POWDER-FREE EXAMINATION GLOVES | Feb 10, 1997 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K963804 | PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES | Feb 10, 1997 | Substantially Equivalent | HARTALEGA SDN BHD |
| K964148 | PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES | Feb 07, 1997 | Substantially Equivalent | HARTALEGA SDN BHD |
| K963771 | CHLOROPRENE EXAM GLOVES | Dec 19, 1996 | Substantially Equivalent | PT. IRAMA DINAMIKA LATEX |
| K962518 | NITRILE COPOLYMER PATIENT EXAMINATION GLOVES | Dec 19, 1996 | Substantially Equivalent | PT. IRAMA DINAMIKA LATEX |
| K962139 | SAFESKIN | Dec 19, 1996 | Substantially Equivalent | SAFESKIN CORP. |
| K962461 | NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES | Aug 14, 1996 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K955464 | TACTYLON POWDER FREE EXAMINATION GLOVE | Apr 25, 1996 | Substantially Equivalent | TACTYL TECHNOLOGIES, INC. |
| K954574 | PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES | Dec 21, 1995 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K954573 | PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES | Dec 21, 1995 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K952154 | SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES | Dec 15, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | Dec 15, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K951938 | SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES | Dec 15, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K954533 | ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES | Dec 11, 1995 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K952155 | SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES | Dec 11, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K952052 | SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) | Oct 30, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K951921 | SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) | Oct 30, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K950033 | POLYDERM | Apr 04, 1995 | Substantially Equivalent | WILSHIRE TECHNOLOGIES |
| K946291 | ELASTYREN(R) PATIENT EXAMINATION GLOVES | Feb 14, 1995 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K901394 | ELASTYREN - EXAMINATION AND DENTAL GLOVES | Aug 10, 1990 | Substantially Equivalent | DANPREN GLOVES A/S |
| K893606 | PATIENT EXAMINATION GLOVES | Mar 09, 1990 | Substantially Equivalent | AUKLAND MFG., INC. |
| K892771 | PATIENT EXAMINATION GLOVES (POLY) | Sep 13, 1989 | Substantially Equivalent | P.A. RESEARCH CORP. |
| K891833 | GLOUCH(TM) PATIENT EXAMINATION GLOVES | Aug 22, 1989 | Substantially Equivalent | VADAX, INC. |
| K892768 | PATIENT EXAMINATION GLOVES (POLY) | Jun 14, 1989 | Substantially Equivalent | PROMEDICA PRODUCTS, INC. |
| K841676 | DISPOSABLE POLY GLOVES | May 22, 1984 | Substantially Equivalent | ABCO DEALERS, INC. |
FEI Numbers
This FDA classification entry is associated with 444 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 445 registration numbers. Click on an entry to view related FDA registrations.