Surgeon'S Gloves
Surgeon's Gloves are disposable gloves made of natural rubber latex or synthetic polymers intended to be worn on the hands in surgical settings to provide a barrier against potentially infectious materials and other contaminants, protecting both the patient and the surgical team. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGO, regulated under 21 CFR 878.4460, within the General, Plastic Surgery medical specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- KGO
- Device Class
- FDA class 1
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, 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 557 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240790 | Polyisoprene Surgical gloves | Aug 23, 2024 | Substantially Equivalent | Suzhou Colour-way New Material Co., Ltd. |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Mar 28, 2024 | Substantially Equivalent | WRP Asia Pacific Sdn. Bhd. |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Dec 20, 2023 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Oct 20, 2023 | Substantially Equivalent | Ansell Healthcare |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Sep 29, 2023 | Substantially Equivalent | Ineo Tech Sdn Bhd |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Sep 22, 2023 | Substantially Equivalent | Fitone Latex Products Co., Ltd. Guangdong |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Aug 31, 2023 | Substantially Equivalent | WRP Asia Pacific Sdn. Bhd. |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Aug 23, 2023 | Substantially Equivalent | Ansell Healthcare Products, LLC. |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Aug 18, 2023 | Substantially Equivalent | Sentienx Sdn Bhd |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | Aug 16, 2023 | Substantially Equivalent | The Egyptian Company For Medical & Electronic Industries |
| K230304 | Polyisoprene Surgical Gloves | Aug 09, 2023 | Substantially Equivalent | Puyang Linshi Medical Supplies Co., Ltd. |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | May 26, 2023 | Substantially Equivalent | Ansell Healthcare Products, LLC |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | May 13, 2023 | Substantially Equivalent | Grand Work Plastic Products Co., Ltd |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Apr 13, 2023 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN. BHD. |
| K222620 | Sterilized Latex Surgical Gloves | Mar 23, 2023 | Substantially Equivalent | Suzhou Colour-way New Material Co., Ltd. |
| K221424 | Sterile Surgical Powder Free Latex Glove | Jan 26, 2023 | Substantially Equivalent | New Era Medicare Sdn. Bhd. |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Oct 22, 2022 | Substantially Equivalent | WRP Asia Pacific SDN. BHD. |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | Sep 24, 2022 | Substantially Equivalent | Hartalega NGC SDN BHD |
| K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Sep 13, 2022 | Substantially Equivalent | Guilin HBM Health Protections, Inc. |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | May 26, 2022 | Substantially Equivalent | Hartalega NGC SDN. BHD. |
| K211953 | Disposable Sterilized Latex Surgical Gloves | May 25, 2022 | Substantially Equivalent | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
| K212596 | Sterile Latex Surgical Gloves Powder Free | Mar 01, 2022 | Substantially Equivalent | Amazing Rubber Products Pvt Ltd |
| K212848 | Sterile Latex Surgical Gloves Powder Free | Dec 27, 2021 | Substantially Equivalent | Pentavest Holdings Sdn Bhd |
| K210969 | Nulife | Nov 03, 2021 | Substantially Equivalent | MRK Healthcare Pvt Ltd |
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | Oct 06, 2021 | Substantially Equivalent | Careplus (M) SDN BHD |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | Sep 26, 2021 | Substantially Equivalent | Cardinal Health 200, LLC |
| K211478 | Sterile Latex Surgical Gloves Powder Free | Sep 16, 2021 | Substantially Equivalent | Aspen Glove Sdn. Bhd. |
| K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Aug 03, 2021 | Substantially Equivalent | Careplus (M) SDN BHD |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) | Aug 02, 2021 | Substantially Equivalent | Medline Industries, Inc. |
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | Jul 09, 2021 | Substantially Equivalent | GX Corporation Sdn Bhd |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Jun 24, 2021 | Substantially Equivalent | Careplus (M) SDN BHD |
| K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Jun 11, 2021 | Substantially Equivalent | WRP ASIA PACIFIC SDN BHD |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | May 27, 2021 | Substantially Equivalent | Careplus (M) SDN BHD |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein | Feb 17, 2021 | Substantially Equivalent | ECO Medi Glove Sdn. Bhd |
| K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Feb 01, 2021 | Substantially Equivalent | Guilin HBM Health Protections, Inc. |
| K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | Jan 13, 2021 | Substantially Equivalent | Emerson & Co. Srl |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein | Dec 19, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Nov 22, 2020 | Substantially Equivalent | Molnlycke Health Care, US LLC |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein | Nov 18, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | Oct 02, 2020 | Substantially Equivalent | Hartalega SDN BHD |
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | Sep 16, 2020 | Substantially Equivalent | PT. Medisafe Technologies |
| K201829 | SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) | Sep 09, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Jun 01, 2020 | Substantially Equivalent | Hartalega SDN. BHD. |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | Apr 10, 2020 | Substantially Equivalent | Molnlycke Health Care US LLC. |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | Apr 06, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K192988 | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use | Apr 01, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential | Mar 31, 2020 | Substantially Equivalent | Semperit Technische Produkte Gesellchaft m.b.H. |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Mar 13, 2020 | Substantially Equivalent | Molnlycke Health Care, US LLC |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | Mar 10, 2020 | Substantially Equivalent | JR Engineering & Medical Technologies (M) SDN.BHD. |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | Mar 06, 2020 | Substantially Equivalent | Medline Industries, Inc |
| K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | Feb 28, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Dec 30, 2019 | Substantially Equivalent | Careglove Global Sdn Bhd |
| K191898 | Sterile Latex Powder-Free Surgical Gloves | Dec 18, 2019 | Substantially Equivalent | Modern Healthcare Corp. |
| K190632 | Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein | Oct 24, 2019 | Substantially Equivalent | Lenora Glove PVT LTD. |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Aug 16, 2019 | Substantially Equivalent | Hartalega Ngc Sdn. Bhd. |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | Jun 28, 2019 | Substantially Equivalent | Hartalega NGC Sdn. Bhd. |
| K190782 | FlexGard Cut-Resistant Glove Liners | Jun 27, 2019 | Substantially Equivalent | LDI Corporation |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | May 24, 2019 | Substantially Equivalent | Molnlycke Health Care, US LLC |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | May 23, 2019 | Substantially Equivalent | Ansell Healthcare Products, LLC. |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | Mar 28, 2019 | Substantially Equivalent | PT. Medisafe Technologies |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Mar 22, 2019 | Substantially Equivalent | Ansell Healthcare Products, LLC. |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs | Jan 09, 2019 | Substantially Equivalent | Smart Glove Corporation Sdn.Bhd. |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | Aug 08, 2018 | Substantially Equivalent | Smart Glove Corporation Sdn.Bhd |
| K171550 | Sterile Latex Surgical Gloves, Powder Free | Jul 13, 2018 | Substantially Equivalent | Sanrea Healthcare Products Pvt Ltd |
| K173304 | Finessis Intense Polyisoprene Surgical Glove | Apr 30, 2018 | Substantially Equivalent | Lucenxia Prescience Ag |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | Apr 20, 2018 | Substantially Equivalent | Pt. Medisafe Technologies |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | Apr 09, 2018 | Substantially Equivalent | Lucenxia Prescience AG |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | Feb 06, 2018 | Substantially Equivalent | Ansell Healthcare Products LLC |
| K172942 | Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein | Jan 08, 2018 | Substantially Equivalent | Beta Healthcare Products Pvt.Ltd. |
| K171987 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Oct 20, 2017 | Substantially Equivalent | Lucenxia Prescience AG |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves | Oct 12, 2017 | Substantially Equivalent | Top Glove SDN BHD |
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | Sep 29, 2017 | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. |
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | Aug 21, 2017 | Substantially Equivalent | TG Medical SDN. BHD. |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | Aug 18, 2017 | Substantially Equivalent | Better Care Plastic Technology Co., Ltd |
| K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | Jun 22, 2017 | Substantially Equivalent | Better Care Plastic Technology Co.,Ltd. |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Jun 15, 2017 | Substantially Equivalent | Cardinal Health, Inc. |
| K170515 | Sterile Nitrile Surgical Gloves, Powder-free | Jun 09, 2017 | Substantially Equivalent | Primus Gloves PVT Limited |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | May 05, 2017 | Substantially Equivalent | HARTALEGA SDN BHD |
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | May 02, 2017 | Substantially Equivalent | SEMPERIT INVESTMENTS ASIA PTE. LTD. |
| K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | Feb 08, 2017 | Substantially Equivalent | Lucenxia Prescience AG |
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | Jan 23, 2017 | Substantially Equivalent | WRP ASIA PACIFIC SDN BHD |
| K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) | Dec 20, 2016 | Substantially Equivalent | HARTALEGA SDB. BHD. |
| K160974 | Gammex Cut-Resistant Glove Liner | Oct 28, 2016 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | Jul 28, 2016 | Substantially Equivalent | HARTALEGA SDN. BHD. |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Jul 11, 2016 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | May 12, 2016 | Substantially Equivalent | Cardinal Health, Inc. |
| K152428 | SensiCare PI Surgical Gloves | Mar 31, 2016 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Mar 24, 2016 | Substantially Equivalent | CARDINAL HEALTH 200, INC. |
| K151694 | Gammex PI Hybrid Surgical Gloves | Mar 09, 2016 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm | Jan 15, 2016 | Substantially Equivalent | EMERSON & CO. S.R.L. |
| K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein | Dec 11, 2015 | Substantially Equivalent | ST.MARYS RUBBERS PVT. LTD. |
| K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | Nov 27, 2015 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Nov 16, 2015 | Substantially Equivalent | Lucenxia Prescience AG |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | Nov 16, 2015 | Substantially Equivalent | Lucenxia Prescience AG |
| K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free) | Nov 16, 2015 | Substantially Equivalent | ANHUI ANYU LATEX PRODUCTS CO., LTD |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | Nov 02, 2015 | Substantially Equivalent | PT MEDISAFE TECHNOLOGIES |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less | Sep 18, 2015 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K150146 | Biogel PI Micro Indicator Underglove | Aug 31, 2015 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K150973 | NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs | Aug 04, 2015 | Substantially Equivalent | TERANG NUSA SND BHD |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs | Jul 14, 2015 | Substantially Equivalent | PT MEDISAFE TECHNOLOGIES |
| K140477 | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES | Mar 23, 2015 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K142992 | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) | Mar 18, 2015 | Substantially Equivalent | SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD |
| K140989 | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) | Dec 22, 2014 | Substantially Equivalent | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
| K140355 | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM | Nov 06, 2014 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K130450 | SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE | Sep 30, 2014 | Substantially Equivalent | PURNA BINA SDN BHD |
| K141719 | BIOGEL PL MICRO SURGICAL GLOVE | Sep 04, 2014 | Substantially Equivalent | MOLNLYCKE HEALTH CARE, US LLC |
| K140988 | POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) | Aug 12, 2014 | Substantially Equivalent | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
| K123126 | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) | Jun 04, 2014 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K132802 | MOTEX POWDERED NITRILE SURGICAL GLOVES | May 21, 2014 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K122557 | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES | Oct 03, 2013 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K131751 | FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES | Sep 25, 2013 | Substantially Equivalent | LUCENXIA PRESCIENCE AG |
| K121925 | POWDERED LATEX SURGEON'S GLOVE | Aug 28, 2013 | Substantially Equivalent | SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
| K130301 | LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) | Aug 22, 2013 | Substantially Equivalent | ELIMEDICAL DEVICES (FUJIAN) INC. |
| K123629 | FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES | May 13, 2013 | Substantially Equivalent | LUCENXIA PRESCIENCE AG |
| K123628 | STERILE LATEX SURGICAL GLOVE | Mar 18, 2013 | Substantially Equivalent | LUCENXIA PRESCIENCE AG |
| K121335 | G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE | Sep 13, 2012 | Substantially Equivalent | HUTCHINSON SANTE S.N.C. |
| K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | Jul 27, 2012 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K120934 | PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS | May 23, 2012 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | Apr 27, 2012 | Substantially Equivalent | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
| K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM | Mar 29, 2012 | Substantially Equivalent | SHEN WEI (USA), INC. |
| K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | Feb 17, 2012 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K111413 | BIOGEL (R) INDICATOR (R) UNDERGLOVE | Jan 30, 2012 | Substantially Equivalent | MOLNLYCKE HEALTHCARE, US LLC |
| K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE | Dec 07, 2011 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | Sep 29, 2011 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | Sep 21, 2011 | Substantially Equivalent | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
| K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE | Sep 20, 2011 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | Sep 02, 2011 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K112089 | BIOGEL ORTHOPOR BROWN SURGICAL GLOVE | Aug 24, 2011 | Substantially Equivalent | MOLNLYCKE HEALTHCARE, US LLC |
| K111807 | MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... | Aug 18, 2011 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | Jul 07, 2011 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K102177 | SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE | Jun 30, 2011 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | Jun 08, 2011 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | May 06, 2011 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K101163 | BIOGEL ORTHOPRO INDICATOR UNDERGLOVE | Nov 23, 2010 | Substantially Equivalent | MOLNLYCKE HEALTH CARE USA |
| K102500 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | Nov 04, 2010 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K101811 | PROTEGRITY SMT LATEX SURGICALGLOVES | Oct 15, 2010 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K102119 | SUR-G GLOV AND MAXITEX | Aug 27, 2010 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K101103 | POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 | Jul 16, 2010 | Substantially Equivalent | BEST PUTRA GLOVES SDN BHD |
| K101102 | POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE | Jul 16, 2010 | Substantially Equivalent | BEST PUTRA GLOVES SDN BHD |
| K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | Oct 30, 2009 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Sep 15, 2009 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | May 15, 2009 | Substantially Equivalent | WEAR SAFE (MALAYSIA) SDN. BHD. |
| K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | Aug 26, 2008 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K073447 | SURGI GLOVES | Apr 24, 2008 | Substantially Equivalent | METACURE SURGICAL GLOVES SDN BHD |
| K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | Dec 13, 2007 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | Sep 11, 2007 | Substantially Equivalent | MOLNLYCKE HEALTHCARE, US LLC |
| K071465 | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT | Sep 11, 2007 | Substantially Equivalent | MOLNLYCKE HEALTHCARE, US LLC |
| K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | Sep 10, 2007 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K071414 | BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Sep 10, 2007 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K063757 | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES | Jul 27, 2007 | Substantially Equivalent | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
| K070619 | POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING | Jun 27, 2007 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K070647 | TRIFLEX SELECT | Jun 22, 2007 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K063582 | ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE | Apr 26, 2007 | Substantially Equivalent | ZIMMER, INC. |
| K062797 | POWDERED LATEX SURGICAL GLOVE | Apr 11, 2007 | Substantially Equivalent | BEIJING REAGENT LATEX PRODUCTS CO., LTD. |
| K062950 | POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) | Dec 21, 2006 | Substantially Equivalent | HARTALEGA SDN BHD |
| K062847 | BIOGEL ECLIPSE INDICATOR UNDERGLOVE | Dec 20, 2006 | Substantially Equivalent | MOLNLYCKE HEALTH CARE US, LLC |
| K053406 | BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | Jul 05, 2006 | Substantially Equivalent | BARRIERMED GLOVE CO. |
| K060030 | THE DOUBLE GLOVE | Jun 27, 2006 | Substantially Equivalent | BIOBARRIER, INC. |
| K061038 | BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 | Jun 23, 2006 | Substantially Equivalent | BARRIERMED GLOVE CO. |
| K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | Apr 10, 2006 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K053102 | BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE | Mar 10, 2006 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K053442 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | Mar 07, 2006 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K053443 | BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE | Feb 01, 2006 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K053272 | CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES | Jan 05, 2006 | Substantially Equivalent | Cardinal Health |
| K052772 | BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES | Dec 20, 2005 | Substantially Equivalent | BARRIERMED GLOVE CO. |
| K052177 | POWDER FREE STERILE LATEX SURGICAL GLOVES | Dec 09, 2005 | Substantially Equivalent | HARTALEGA SDN BHD |
| K052837 | SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA | Nov 21, 2005 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K051562 | NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR | Oct 20, 2005 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K052030 | SURGEON'S GLOVE, POWDER FREE | Sep 13, 2005 | Substantially Equivalent | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
| K052031 | POWDERED LATEX SURGEON'S GLOVE | Sep 12, 2005 | Substantially Equivalent | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
| K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) | Aug 17, 2005 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K050899 | BIOGEL LATEX STERILE POWDER-FREE GLOVE | Aug 12, 2005 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K051563 | NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED | Jun 20, 2005 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K051094 | NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE | Jun 06, 2005 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K050071 | MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE | May 11, 2005 | Substantially Equivalent | H.B.M. USA CO.,INC. |
| K042534 | MARINA MEDICAL FINGER PROTECTORS | May 10, 2005 | Substantially Equivalent | MARINA MEDICAL INSTRUMENTS, INC. |
| K050533 | ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE | Apr 26, 2005 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K050181 | MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | Apr 13, 2005 | Substantially Equivalent | MEDIGLOVES LTD. |
| K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | Mar 16, 2005 | Substantially Equivalent | REGENT MEDICAL AMERICAS, LLC |
| K043508 | DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | Jan 19, 2005 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K042567 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E | Jan 13, 2005 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K042574 | ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) | Dec 08, 2004 | Substantially Equivalent | Cardinal Health |
| K041437 | MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE | Sep 16, 2004 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K041436 | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 | Aug 20, 2004 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K031368 | POWDERED LATEX SURGEON'S GLOVES | Jun 22, 2004 | Substantially Equivalent | CEPHAS MEDICAL PRIVATE LTD. |
| K033905 | PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING | Apr 27, 2004 | Substantially Equivalent | Cardinal Health |
| K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR | Mar 16, 2004 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K033564 | POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 | Feb 24, 2004 | Substantially Equivalent | KANAM LATEX INDUSTRIES PVT. LTD. |
| K032942 | PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE | Dec 17, 2003 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K032647 | ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA | Nov 07, 2003 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K023139 | ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE | Oct 22, 2003 | Substantially Equivalent | VAN OOSTVEEN MEDICAL B.V. |
| K032501 | MAXTER STERILE POWDER FREE SURGICAL GLOVES | Oct 17, 2003 | Substantially Equivalent | MAXTER GLOVE MANUFACTURING SDN BHD |
| K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING | Oct 15, 2003 | Substantially Equivalent | Cardinal Health |
| K032467 | MAXTER STERILE POWDERED LATEX SURGICAL GLOVES | Oct 10, 2003 | Substantially Equivalent | MAXTER GLOVE MANUFACTURING SDN BHD |
| K031670 | STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING | Sep 23, 2003 | Substantially Equivalent | P.T. SAPTINDO SURGICA |
| K031669 | STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING | Sep 23, 2003 | Substantially Equivalent | P.T. SAPTINDO SURGICA |
| K032464 | ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 | Aug 22, 2003 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K031130 | YA MEI FIRST AID KIT | Jun 27, 2003 | Substantially Equivalent | YA MEI TECHNOLOGY CO., LTD. |
| K030445 | POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM | Jun 05, 2003 | Substantially Equivalent | PRIMUS GLOVES PRIVATE LTD. |
| K030444 | PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES | Jun 05, 2003 | Substantially Equivalent | PRIMUS GLOVES PRIVATE LTD. |
| K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) | Mar 21, 2003 | Substantially Equivalent | INTERNATIONAL BIOMEDICAL, INC. |
| K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | Mar 14, 2003 | Substantially Equivalent | PT. MEDISAFE TECHNOLOGIES |
| K023912 | POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM | Feb 11, 2003 | Substantially Equivalent | SANREA HEALTHCARE PRIVATE LIMITED |
| K023515 | PRE-POWDERED LATEX SURGEON'S GLOVES | Jan 16, 2003 | Substantially Equivalent | SANREA HEALTHCARE PRIVATE LIMITED |
| K024130 | POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE | Dec 30, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Nov 12, 2002 | Substantially Equivalent | MAXXIM MEDICAL |
| K022444 | POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA | Sep 17, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K022442 | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) | Sep 05, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K021784 | PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | Jul 24, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K021119 | POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM | Jul 05, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K021159 | POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM | Jul 03, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K021598 | ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE | Jun 10, 2002 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K014283 | LATEX SURGEONS GLOVE (POWDER FREE) | May 22, 2002 | Substantially Equivalent | BRIGHTWAY GLOVES PVT. LTD. |
| K014278 | LATEX SURGEONS GLOVE (POWDERED) | May 14, 2002 | Substantially Equivalent | BRIGHTWAY GLOVES PVT. LTD. |
| K021065 | PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM | May 08, 2002 | Substantially Equivalent | PRIMUS GLOVES PRIVATE LTD. |
| K020918 | ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE | Apr 19, 2002 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K020308 | REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE | Apr 03, 2002 | Substantially Equivalent | SSL AMERICA'S, INC. |
| K014230 | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | Mar 13, 2002 | Substantially Equivalent | SUPERMAX GLOVE MANUFACTURING SDN BHD |
| K014288 | DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS | Feb 13, 2002 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K013914 | POWDERFREE LATEX SURGEON'S GLOVES | Feb 06, 2002 | Substantially Equivalent | KANAM LATEX INDUSTRIES PVT. LTD. |
| K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | Jan 23, 2002 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K013560 | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 | Jan 16, 2002 | Substantially Equivalent | SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
| K013302 | DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM | Dec 17, 2001 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K013727 | STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G | Dec 07, 2001 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K013324 | HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT | Nov 29, 2001 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K012896 | STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) | Nov 16, 2001 | Substantially Equivalent | SSN GLOVES (M) SDN BHD |
| K012880 | STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) | Nov 16, 2001 | Substantially Equivalent | SSN GLOVES (M) SDN BHD |
| K012819 | SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 | Nov 16, 2001 | Substantially Equivalent | SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
| K013604 | MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES | Nov 13, 2001 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K013603 | MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 | Nov 13, 2001 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K012479 | STERILE NITRILE SURGICAL GLOVES (POWDERED) | Sep 26, 2001 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K012067 | CLINCARE LATEX SURGEON'S GLOVE | Sep 17, 2001 | Substantially Equivalent | TTK HEALTHCARE LTD. |
| K011066 | STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) | Sep 11, 2001 | Substantially Equivalent | SMART GLOVE CORP. SDN BHD |
| K012104 | SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES | Aug 21, 2001 | Substantially Equivalent | BEIJING REAGENT LATEX PRODUCTS CO., LTD. |
| K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES | Aug 14, 2001 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K012135 | POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Aug 01, 2001 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K011446 | BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | Jun 14, 2001 | Substantially Equivalent | BARRIERMED, INC. |
| K010862 | ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER | Jun 07, 2001 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K010439 | MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) | May 01, 2001 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K010438 | MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) | May 01, 2001 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K010198 | STERILE POWDERED LATEX SURGEON GLOVES | Feb 23, 2001 | Substantially Equivalent | SUPERMAX GLOVE MANUFACTURING SDN BHD |
| K003895 | X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 | Jan 17, 2001 | Substantially Equivalent | ANSELL PERRY |
| K003771 | ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Jan 16, 2001 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K003769 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 | Dec 22, 2000 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, INC. |
| K002593 | POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Nov 29, 2000 | Substantially Equivalent | HARTALEGA SDN BHD |
| K003063 | GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION | Nov 22, 2000 | Substantially Equivalent | GIMBEL GLOVE CO., LLC. |
| K003019 | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE | Nov 03, 2000 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Oct 19, 2000 | Substantially Equivalent | MAXXIM MEDICAL |
| K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | Aug 14, 2000 | Substantially Equivalent | SSL AMERICAS, INC. (REGENT MEDICAL) |
| K002192 | DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 | Jul 27, 2000 | Substantially Equivalent | ANSELL PERRY |
| K001959 | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | Jul 26, 2000 | Substantially Equivalent | HARTALEGA SDN BHD |
| K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 | Jul 14, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Jun 23, 2000 | Substantially Equivalent | P.T. MAJA AGUNG LATEXINDO |
| K001343 | EUDERMIC PF POWDER-FREE SURGICAL GLOVES | Jun 12, 2000 | Substantially Equivalent | MAXXIM MEDICAL, INC. |
| K001049 | GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) | May 23, 2000 | Substantially Equivalent | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
| K000178 | NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN | May 23, 2000 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K001239 | ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | May 15, 2000 | Substantially Equivalent | ANSELL PERRY |
| K000179 | NUZONE NITRILE SURGICAL GLOVES POWDER FREE | May 15, 2000 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K000896 | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS | May 03, 2000 | Substantially Equivalent | FITCO DIPPED PRODUCTS PVT. LTD |
| K993756 | HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES | Apr 28, 2000 | Substantially Equivalent | PAMITEX INDUSTRIES SDN BHD |
| K001047 | GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) | Apr 28, 2000 | Substantially Equivalent | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
| K000971 | PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE | Apr 14, 2000 | Substantially Equivalent | WRP ASIA PACIFIC SDN. BHD. |
| K993201 | HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES | Mar 29, 2000 | Substantially Equivalent | PAMITEX INDUSTRIES SDN BHD |
| K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Feb 16, 2000 | Substantially Equivalent | ANSELL PERRY |
| K993857 | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR | Jan 31, 2000 | Substantially Equivalent | ANSELL PERRY |
| K994081 | SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES | Jan 18, 2000 | Substantially Equivalent | SAFESKIN CORP. |
| K993562 | POWDER FREE LATEX STERILE SURGICAL GLOVES | Dec 29, 1999 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K993450 | LATEX SURGICAL GLOVES, PRE-POWDERED | Dec 29, 1999 | Substantially Equivalent | FITCO DIPPED PRODUCTS PVT. LTD |
| K993215 | DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE | Dec 02, 1999 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K993214 | DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) | Dec 02, 1999 | Substantially Equivalent | WRP SPECIALTY PRODUCTS SDN. BHD. |
| K993349 | NIL, SURGEON'S GLOVE - POWDER FREE | Nov 23, 1999 | Substantially Equivalent | SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | Nov 05, 1999 | Substantially Equivalent | P.T. MAJA AGUNG LATEXINDO |
| K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | Oct 29, 1999 | Substantially Equivalent | ANSELL PERRY |
| K992679 | SURGEON POWDER-FREE GLOVES, LATEX, STERILE | Oct 21, 1999 | Substantially Equivalent | WEAR SAFE MALAYSIA SDN. BHD. |
| K991205 | ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Oct 13, 1999 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K992171 | COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Sep 14, 1999 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K991950 | LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) | Aug 12, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K991949 | LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) | Aug 12, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K992019 | LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Aug 05, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K992219 | POWDERED LATEX STERILE SURGICAL GLOVES | Jul 30, 1999 | Substantially Equivalent | TG MEDICAL SDN BHD |
| K992018 | LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) | Jul 30, 1999 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K992020 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) | Jul 26, 1999 | Substantially Equivalent | BRIGHTSWAY HOLDINGS SDN BHD |
| K992021 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) | Jul 23, 1999 | Substantially Equivalent | BRIGHTSWAY HOLDINGS SDN BHD |
| K991992 | ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES | Jul 13, 1999 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K991940 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) | Jul 12, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K984512 | NITRILON CORRECT-TOUCH | Jul 12, 1999 | Substantially Equivalent | CT INTL. |
| K991939 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) | Jul 01, 1999 | Substantially Equivalent | BRIGHTWAY HOLDINGS SDN. BHD. |
| K991317 | POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | May 21, 1999 | Substantially Equivalent | SAFESKIN CORP. |
| K984395 | SURGEON'S GLOVES | May 21, 1999 | Substantially Equivalent | SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
| K990710 | BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES | May 20, 1999 | Substantially Equivalent | BARRIERMED GLOVE CO. |
| K983982 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES | May 04, 1999 | Substantially Equivalent | MAXXIM MEDICAL |
| K984337 | ELASTYLON POWDER-FREE SURGICAL GLOVE | Apr 09, 1999 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | Mar 12, 1999 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K981947 | STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) | Mar 03, 1999 | Substantially Equivalent | BOSTON MEDICAL CORP. |
| K984559 | ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | Feb 26, 1999 | Substantially Equivalent | ANSELL PERRY |
| K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | Feb 26, 1999 | Substantially Equivalent | ANSELL PERRY |
| K984066 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM | Jan 13, 1999 | Substantially Equivalent | OMNI INTL., INC. |
| K982957 | SENSIFLEX POWDERFREE SURGEON'S GLOVE | Jan 13, 1999 | Substantially Equivalent | TERANG NUSA SDN BHD |
| K984064 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE | Jan 08, 1999 | Substantially Equivalent | OMNI INTL., INC. |
| K983962 | ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES | Jan 08, 1999 | Substantially Equivalent | CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES |
| K983489 | ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) | Dec 14, 1998 | Substantially Equivalent | ANSELL PERRY |
| K983240 | NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES | Nov 30, 1998 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
| K981096 | SEMPERMED SURGEONS' GLOVES - SUPREME | Oct 29, 1998 | Substantially Equivalent | SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
| K982589 | SURGEON'S GLOVE | Sep 10, 1998 | Substantially Equivalent | SHIVA MEDICARE LTD. |
| K982613 | OMNI PRO LATEX SURGICAL GLOVE, POWDERED | Sep 02, 1998 | Substantially Equivalent | OMNIGRACE (THAILAND) LTD. |
| K982586 | POWDER FREE SURGEONS GLOVE | Aug 11, 1998 | Substantially Equivalent | SHIVA MEDICARE LTD. |
| K980929 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES | Jun 05, 1998 | Substantially Equivalent | ANSELL PERRY |
| K980880 | SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) | May 20, 1998 | Substantially Equivalent | ANSELL PERRY |
| K981392 | ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE | May 11, 1998 | Substantially Equivalent | ANSELL PERRY |
| K980942 | REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE | May 11, 1998 | Substantially Equivalent | LONDON INTERNATIONAL GROUP, INC. |
| K980516 | REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE | Apr 23, 1998 | Substantially Equivalent | LONDON INTERNATIONAL GROUP, INC. |
| K980412 | COLOURED POWDWR-FREE SURGICAL GLOVES | Apr 08, 1998 | Substantially Equivalent | KENWELL INTERNATIONAL LTD. |
| K980564 | MEDI-GRIP (BEIGE 43)SURGICAL GLOVES | Mar 25, 1998 | Substantially Equivalent | ANSELL PERRY |
| K974783 | ENCORE MARK IV POWDER FREE SURGICAL GLOVES | Feb 09, 1998 | Substantially Equivalent | ANSELL PERRY |
| K971471 | ELASTYREN POWDER-FREE SURGICAL GLOVE | Feb 09, 1998 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K974356 | SURGEON'S GLOVES | Jan 29, 1998 | Substantially Equivalent | AMERICAN HEALTH PRODUCTS, INC. |
| K970795 | SHANG HO | Dec 18, 1997 | Substantially Equivalent | SHANG HO INDUSTRIAL CORP. LTD. |
| K973699 | ULTRALON POWDER FREE LATEX SURGICAL GLOVE | Dec 16, 1997 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K973461 | ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE | Dec 09, 1997 | Substantially Equivalent | ANSELL PERRY |
| K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | Oct 24, 1997 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K972277 | DIGIFLEX SURGICAL GLOVES | Oct 21, 1997 | Substantially Equivalent | HMS SERVICES, INC. |
| K972009 | PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE | Sep 12, 1997 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K970160 | UNIJECT SURGICAL GLOVES | Jul 15, 1997 | Substantially Equivalent | UNIJECT GLOVES LTD. |
| K971945 | PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE | Jul 14, 1997 | Substantially Equivalent | TILLOTSON HEALTHCARE CORP. |
| K962539 | GANTEX MODEL NSG-75PF | Jul 14, 1997 | Substantially Equivalent | AMERICAN PRO LATEX, INC. |
| K971381 | POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES | Jul 09, 1997 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K964440 | EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS) | Apr 22, 1997 | Substantially Equivalent | MAXXIM MEDICAL |
| K970924 | REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE | Apr 01, 1997 | Substantially Equivalent | REGENT MEDICAL |
| K964474 | ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES | Mar 11, 1997 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K964980 | ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM | Mar 06, 1997 | Substantially Equivalent | MAXXIM MEDICAL |
| K964962 | SENTURA SURGICAL GLOVES | Mar 06, 1997 | Substantially Equivalent | MAXXIM MEDICAL |
| K962813 | DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES | Jan 30, 1997 | Substantially Equivalent | MAXXIM MEDICAL |
| K963020 | GLOVEL GX | Nov 27, 1996 | Substantially Equivalent | KENWELL INTERNATIONAL LTD. |
| K963218 | BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE | Oct 30, 1996 | Substantially Equivalent | AMERICAN BANTEX CORP. |
| K962724 | STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED | Oct 29, 1996 | Substantially Equivalent | SONNHEIM MEDIKAL GMBH |
| K962837 | NULIFE | Oct 02, 1996 | Substantially Equivalent | MED-TECH RUBBER & ENGINEERING INDUSTRIES |
| K962986 | MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES | Sep 20, 1996 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K961632 | MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES | Jul 03, 1996 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K954325 | NEOLON NEOPRENE SURGICAL GLOVES | May 14, 1996 | Substantially Equivalent | MAXXIM MEDICAL |
| K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) | May 06, 1996 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K960416 | COMFIT MICROPTIC | Apr 26, 1996 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K960407 | COMFIT ORTHOPEDIC | Apr 26, 1996 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K955419 | POWDER FREE TACTYLON SURGEONS GLOVE | Apr 15, 1996 | Substantially Equivalent | TACTYL TECHNOLOGIES, INC. |
| K954002 | AMPRI | Jan 29, 1996 | Substantially Equivalent | AMPRI RUBBERWARE INDUSTRIES SDN BHD |
| K953358 | SURGEONS GLOVE POWDER FREE | Dec 28, 1995 | Substantially Equivalent | AMERICAN PRO LATEX, INC. |
| K954535 | ELASTYREN HYPOALLERGENIC SURGICAL GLOVES | Dec 11, 1995 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K954025 | SIME SURGICAL POWDERFREE | Nov 15, 1995 | Substantially Equivalent | SIME HEALTH, LTD. |
| K954462 | POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES | Oct 13, 1995 | Substantially Equivalent | INTL. TRADE MANAGEMENT CO. |
| K953712 | DERRICK SURESHIELD | Oct 12, 1995 | Substantially Equivalent | M.P.S. PHARM'L INT'L |
| K953639 | NEUTRALON BROWN LATEX SURGICAL GLOVES | Oct 12, 1995 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K954049 | MICRO-TOUCH* LATEX SURGICAL GLOVES | Oct 05, 1995 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K953641 | MAXXUS ORTHOPAEDIC SURGICAL GLOVES | Sep 15, 1995 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K951908 | REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE | Sep 01, 1995 | Substantially Equivalent | REGENT HOSPITAL PRODUCTS |
| K953015 | SAFESKIN SUPRA | Aug 28, 1995 | Substantially Equivalent | SAFESKIN CORP. |
| K952993 | SAFESKIN SUPRA | Aug 28, 1995 | Substantially Equivalent | SAFESKIN CORP. |
| K945505 | ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE | Aug 18, 1995 | Substantially Equivalent | GANZ INDUSTRIES SDN. BHD. |
| K945948 | ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES | Jul 31, 1995 | Substantially Equivalent | AMPRI RUBBERWARE INDUSTRIES SDN BHD |
| K951473 | ULTIMAX | Jul 17, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K951662 | COMFIT/BEADED SURGEON'S GLOVE | May 17, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K951661 | PROFEEL | May 17, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K950468 | POWDER FREE STERILE LATEX SURGEONS GLOVES | Apr 25, 1995 | Substantially Equivalent | INTL. TRADE MANAGEMENT CO. |
| K944053 | NATURAL RUBBER LATEX SURGEONS GLOVE | Apr 25, 1995 | Substantially Equivalent | ARENT FOX |
| K950185 | TACTYLON(TM) POWDER FREE SURGEONS GLOVE | Apr 13, 1995 | Substantially Equivalent | TACTYL TECHNOLOGIES, INC. |
| K945363 | MEDI PLUS SURGEON'S GLOVES | Mar 07, 1995 | Substantially Equivalent | P.T. SAPTINDO SURGICA |
| K943255 | SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) | Mar 07, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K943254 | SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) | Mar 07, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K945158 | MICRO-TOUCH LP LATEX SURGICAL GLOVES | Feb 13, 1995 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K945157 | MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES | Feb 13, 1995 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K943674 | NEUTRALON LP BROWN LATEX SURGICAL GLOVES | Feb 13, 1995 | Substantially Equivalent | MAXXIM MEDICAL |
| K943566 | ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) | Feb 03, 1995 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K922979 | STERILE EXTRA PROTECION SURGEON'S GLOVES | Jan 18, 1995 | Substantially Equivalent | ANSELL MALAYSIA SDN BHD |
| K945833 | ELASTYREN(R) SURGICAL GLOVES | Jan 17, 1995 | Substantially Equivalent | ECI MEDICAL TECHNOLOGIES, INC. |
| K941770 | DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES | Jul 05, 1994 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K940218 | SURESOFT SURGICAL GLOVES | May 16, 1994 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K940797 | SIME SURGICAL LATEX GLOVE | May 09, 1994 | Substantially Equivalent | SIME HEALTH, LTD. |
| K935464 | COMFIT | May 09, 1994 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K935227 | MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES | Mar 07, 1994 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K935869 | DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES | Feb 24, 1994 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K935870 | DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS | Feb 18, 1994 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K925861 | GIMBEL PUNCTURE RESISTANT SURGICAL GLOVE | Feb 04, 1994 | Substantially Equivalent | GIMBEL GLOVE CO. |
| K930794 | MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES | Feb 03, 1994 | Substantially Equivalent | MEDIGLOVES LTD. |
| K933062 | B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES | Jan 31, 1994 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K932665 | ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC | Dec 22, 1993 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K932664 | ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA | Dec 22, 1993 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K924071 | INTEGRON SURGICAL GLOVES | Nov 18, 1993 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K932061 | MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM | Nov 16, 1993 | Substantially Equivalent | ADVANCED CHEMICAL TECHNOLOGY, INC. |
| K925030 | SURGEON'S GLOVE | Jul 13, 1993 | Substantially Equivalent | WUHRLIN SOPLAMED (M) SDN BHD |
| K923929 | PERRY POWDER-FREE GLOVES, STYLE 45G | Feb 10, 1993 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K922116 | POWDER FREE NITRILE GLOVE | Feb 08, 1993 | Substantially Equivalent | HPI, INC. |
| K923576 | STERILE NATURAL RUBBER LATEX SURGIONS' GLOVES | Jan 29, 1993 | Substantially Equivalent | MRI CORP. |
| K920745 | NUTEX GLOVES | Jan 21, 1993 | Substantially Equivalent | ANSELL INTL. |
| K915218 | ULTRALON POWDERFREE SURGICAL GLOVES | Dec 15, 1992 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K920876 | CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER | Dec 11, 1992 | Substantially Equivalent | MEDTECH INTL., INC. |
| K922515 | PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER) | Nov 25, 1992 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K921804 | DEXTRON SURGICAL GLOVES | Oct 28, 1992 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K915807 | EUDERMIC POWDER-FREE SURGICAL GLOVES | Oct 28, 1992 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K913893 | RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE | Oct 23, 1992 | Substantially Equivalent | DEPUY, INC. |
| K922769 | STERILE SURGEONS GLOVES -- MODIFICATION | Oct 06, 1992 | Substantially Equivalent | REAL LATEX PVT. LTD. |
| K921664 | BIO-GUARD LATEX SURGICAL GLOVES | Sep 23, 1992 | Substantially Equivalent | NETWORK MEDICAL SYSTEMS, INC. |
| K914097 | SAFEMED LATEX SURGICAL GLOVES | Aug 14, 1992 | Substantially Equivalent | SAFETYTECH SDN. BHD. |
| K915086 | HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES | Jun 17, 1992 | Substantially Equivalent | HPI, INC. |
| K914445 | PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45 | Apr 22, 1992 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K914824 | HYPOALLERGENIC SURGEON'S GLOVES - STERILE | Jan 17, 1992 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K913402 | PERRY(R) DERMAGUARD(R) PLUS GLOVES | Oct 02, 1991 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K913215 | SURGIFIT STERILE SURGICAL GLOVES | Sep 23, 1991 | Substantially Equivalent | HEVEALACTICS INTL. SDN BHD |
| K912478 | SEVACARE STERILE SURGEON'S GLOVES | Sep 23, 1991 | Substantially Equivalent | SEVAIDS INDUSTRIES |
| K913207 | TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE | Sep 11, 1991 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K912157 | HYPOALLERGENIC SURGICAL LATEX GLOVES | Sep 06, 1991 | Substantially Equivalent | MEDIGLOVES LTD. |
| K910895 | SURGICAL GLOVES | Jul 22, 1991 | Substantially Equivalent | INFLUX PACIFIC SDN. BHD. |
| K912797 | PERRY NATURAL POWDER FREE GLOVES | Jul 19, 1991 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K911134 | SURGICAL GLOVES | Jul 12, 1991 | Substantially Equivalent | KENWELL INTERNATIONAL LTD. |
| K911268 | SURGICAL RUBBER GLOVES | Jun 13, 1991 | Substantially Equivalent | PACIFICLINK EXPORT |
| K910928 | RUBBER LATEX SURGEONS GLOVES | Jun 13, 1991 | Substantially Equivalent | REGENT HOSPITAL PRODUCTS |
| K911245 | EUDERMIC SURGICAL GLOVES | Apr 25, 1991 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K905624 | PROBE SURGEON'S GLOVES- STERILE | Apr 08, 1991 | Substantially Equivalent | GLOVE INDIA PVT. LTD. |
| K910711 | AMPRO SURGEON'S GLOVES | Mar 29, 1991 | Substantially Equivalent | AMERICAN PRO LATEX, INC. |
| K910383 | HPI SENSI-SHIELD GLOVE KIT | Mar 20, 1991 | Substantially Equivalent | HPI, INC. |
| K902449 | STERILE SURGEON'S GLOVES | Mar 12, 1991 | Substantially Equivalent | UNIGLOVES LTD. |
| K904244 | SENSIDERM | Feb 06, 1991 | Substantially Equivalent | ANSELL INTL. |
| K904972 | SURGICARE STERILE SURGICAL GLOVES | Jan 31, 1991 | Substantially Equivalent | KANAM LATEX INDUSTRIES PVT. LTD. |
| K904769 | SENSITOUCH | Jan 28, 1991 | Substantially Equivalent | ANSELL INTL. |
| K905537 | PERRY XTENDA CUFF SURGICAL GLOVES | Jan 11, 1991 | Substantially Equivalent | SMITH & NEPHEW PERRY |
| K904662 | SRI JOHANI LATEX SURGEONS GLOVES | Jan 11, 1991 | Substantially Equivalent | TRANSCORP |
| K905012 | STERILE SURGICAL GLOVES/DOUBLE GLOVER | Dec 21, 1990 | Substantially Equivalent | AMERICAN ADVISORS, INC. |
| K904361 | KLEARTEX LATEX SURGEONS GLOVES | Dec 07, 1990 | Substantially Equivalent | KLEARTEX SDN BHD |
| K905161 | RUBBER LATEX SURGICAL GLOVES, STERILE | Nov 29, 1990 | Substantially Equivalent | RFB LATEX PVT. LTD. |
| K904320 | STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX) | Nov 07, 1990 | Substantially Equivalent | R.K.F. LABORATORIES, INC. |
| K903987 | TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED | Oct 11, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K903446 | COMFIT SURGEON'S GLOVES | Oct 01, 1990 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K902714 | LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD) | Sep 19, 1990 | Substantially Equivalent | QUINHUANGDA YUETONG ENT. CO., LTD. |
| K903513 | SANOFLEX-STERILE LATEX SURGICAL GLOVES | Sep 14, 1990 | Substantially Equivalent | LOWENKAMP INTL., INC. |
| K903534 | SURGEON'S (SURGICAL) GLOVES | Aug 17, 1990 | Substantially Equivalent | STRAITSCOM |
| K903069 | KLEARTEX LATEX SURGICAL GLOVES | Aug 07, 1990 | Substantially Equivalent | TRANSCORP |
| K903212 | LATEX SURGICAL STERILE GLOVES | Aug 01, 1990 | Substantially Equivalent | MIRAGE MEDICAL & CHEMICAL, INC. |
| K902831 | TACTYLON TM SURGICAL GLOVE | Jul 10, 1990 | Substantially Equivalent | TACTYL TECHNOLOGIES, INC. |
| K900587 | SEMPERMED SURGEON'S GLOVES | Jul 03, 1990 | Substantially Equivalent | SEMPERIT INDUSTRIAL PRODUCTS |
| K900298 | GAMASHIELD | Jun 27, 1990 | Substantially Equivalent | FORMTEX MEDICAL SDN. BHD. |
| K902380 | TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE | Jun 18, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K901398 | LATEX SURGEON GLOVES | May 16, 1990 | Substantially Equivalent | SINOCHEM (USA), INC. |
| K894828 | HPI ORTHO SURGEONS' GLOVE | May 07, 1990 | Substantially Equivalent | TILLOTSON RUBBER CO., INC. |
| K900669 | HYPO-ALLERGENIC SURGICAL GLOVES | Apr 16, 1990 | Substantially Equivalent | MODERN RUBBER INDUSTRIAL CO., LTD. |
| K894087 | SURGEON'S GLOVES | Apr 04, 1990 | Substantially Equivalent | SHANGRILA LATEX INDUSTRIES PVT. LTD. |
| K901359 | VITAL SURGICAL GLOVES | Apr 03, 1990 | Substantially Equivalent | MASTERVEST CORP. SDN BHD. |
| K900985 | SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS | Mar 20, 1990 | Substantially Equivalent | PRODUCTES DEL LATEX, S.A. |
| K900296 | SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES | Mar 14, 1990 | Substantially Equivalent | P.T. LATEXINDO PRAUTAMA |
| K896675 | STERLING STYLE 90 SURGICAL GLOVES | Mar 08, 1990 | Substantially Equivalent | STERIL RUBBER SDN. BHD. |
| K895230 | STERILE SURGEON'S GLOVES (C T R GLOVES) | Feb 22, 1990 | Substantially Equivalent | TAN D. W. TRADING CO., INC. |
| K895018 | SURGICAL GLOVES | Feb 16, 1990 | Substantially Equivalent | LON TAI CHEMICAL INDUSTRIAL CO., LTD. |
| K897192 | TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE | Feb 15, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K896432 | RUBBER LATEX SURGEON'S GLOVE | Feb 01, 1990 | Substantially Equivalent | REGENT HOSPITAL PRODUCTS |
| K895823 | SURGEON'S GLOVES | Jan 24, 1990 | Substantially Equivalent | GUEY HER ENT. CO. LTD. |
| K892899 | STERILE LATEX SURGICAL GLOVE | Jan 17, 1990 | Substantially Equivalent | TOMARC (M) SDN BHD |
| K893834 | ACCUMED LATEX SURGICAL GLOVE | Dec 14, 1989 | Substantially Equivalent | ACCURATE MEDICAL DEVICES, INC. |
| K896051 | LONE STAR TRADING SURGICAL GLOVE | Nov 28, 1989 | Substantially Equivalent | LONE STAR TRADING PTE. LTD. |
| K896165 | STERILE HYPOALLERGENIC SURGEONS' GLOVES | Nov 22, 1989 | Substantially Equivalent | ISRATECH MARKETING CORP. |
| K892922 | LATEX SURGICAL GLOVES | Nov 21, 1989 | Substantially Equivalent | MILLIMAX CORP. |
| K894928 | STERILE LATEX SURGEON'S GLOVES | Nov 15, 1989 | Substantially Equivalent | GIGANTIC INTERNATIONAL CORP. |
| K896327 | SURGEON'S GLOVES | Nov 08, 1989 | Substantially Equivalent | PRODUCTES DEL LATEX, S.A. |
| K895669 | POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES | Nov 03, 1989 | Substantially Equivalent | SAFESKIN CORP. |
| K894256 | STERILE SURGEONS GLOVES | Oct 31, 1989 | Substantially Equivalent | CHUNG SHIANG RUBBER INDUSTRIAL CO. |
| K894010 | SURGICAL GLOVES | Oct 27, 1989 | Substantially Equivalent | GREEN CROSS MEDICAL SUPPLIES CORP. |
| K891404 | STERILE LATEX SURGEON'S GLOVES | Oct 16, 1989 | Substantially Equivalent | SHINHENG CORP. |
| K892499 | SAFETY SURGEONS GLOVES | Oct 11, 1989 | Substantially Equivalent | ADVANCE RUBBER, INC. |
| K892495 | SURGEON'S GLOVES | Oct 11, 1989 | Substantially Equivalent | CARE-PRO INDUSTRIES, INC. |
| K895448 | RUBBER LATEX SURGICAL GLOVES, STERILE | Oct 10, 1989 | Substantially Equivalent | DAH LEE RUBBER INDUSTRIES (THAI) LTD. |
| K895603 | S.S.T. SURGICAL THIMBLE | Oct 06, 1989 | Substantially Equivalent | HEALTHCARE TECHNOLOGIES RESOURCES, INC. |
| K895027 | MEDPRIDE LATEX SURGEONS GLOVES | Sep 26, 1989 | Substantially Equivalent | MEDPRIDE |
| K894073 | INAMED PRO-TEC SILICONE SURGICAL GLOVES | Sep 18, 1989 | Substantially Equivalent | INAMED DEVELOPMENT CO. |
| K892108 | STERILE NATURAL LATEX SURGICAL GLOVES | Sep 08, 1989 | Substantially Equivalent | RUHN CHANG INDUSTRIAL CO., LTD. |
| K893899 | STERILE LATEX SURGICAL GLOVES | Sep 06, 1989 | Substantially Equivalent | LIFE FORCE LABORATORIES, INC. |
| K892176 | CORRECT TOUCH SURGEONS GLOVES | Sep 06, 1989 | Substantially Equivalent | AMPRI RUBBERWARE INDUSTRIES SDN BHD |
| K891622 | STERILE SURGICAL NATURAL LATEX GLOVES | Sep 06, 1989 | Substantially Equivalent | CT INTL. |
| K894354 | SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES | Aug 23, 1989 | Substantially Equivalent | SAFESKIN CORP. |
| K894501 | AMMEL STERILE SURGEON'S GLOVES | Aug 10, 1989 | Substantially Equivalent | MAURICIO MENCONI |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | Jul 14, 1989 | Substantially Equivalent | JAMES RIVER CORP. |
| K884495 | SURGICAL GLOVES | Jul 14, 1989 | Substantially Equivalent | SANKO CHEMICAL INDUSTRY CO., LTD. |
| K885089 | SURGICAL GLOVES | Jun 22, 1989 | Substantially Equivalent | WB INTL., INC. |
| K893340 | LATEX SURGICAL GLOVES | Jun 21, 1989 | Substantially Equivalent | KENMARK INDUSTRIAL CO., LTD. |
| K892056 | SURGICAL LATEX STERILE GLOVES | Jun 08, 1989 | Substantially Equivalent | MODERN RUBBER INDUSTRIAL CO., LTD. |
| K884882 | ORIENT, LATEX SURGICAL GLOVES, STERILE | May 24, 1989 | Substantially Equivalent | ROSA INTL. |
| K892061 | GRAND GUARD SURGICAL GLOVES | May 23, 1989 | Substantially Equivalent | GALAXY INTL., INC. |
| K885271 | BDAC OMICRON PLUS SURGICAL GLOVES | May 08, 1989 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K892285 | MODERN (STERILE SURGEON'S GLOVES) | May 05, 1989 | Substantially Equivalent | FIRESTONE FINANCIAL CORP. |
| K890289 | DIVERSI-MED STERILE LATEX SURGEON'S GLOVES | May 05, 1989 | Substantially Equivalent | DIVERSI GROUP, INC. |
| K892064 | LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN | Apr 26, 1989 | Substantially Equivalent | MODERN RUBBER INDUSTRIAL CO., LTD. |
| K891308 | STERILE SURGICAL GLOVES | Apr 26, 1989 | Substantially Equivalent | CARL PARKER ASSOCIATES, INC. |
| K884328 | CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) | Apr 26, 1989 | Substantially Equivalent | SELECT SOURCES, INC. |
| K891621 | STERILE SURGEONS' GLOVES | Apr 20, 1989 | Substantially Equivalent | ALBORS-MENCONI LATEX CORP. |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | Apr 20, 1989 | Substantially Equivalent | JAMES RIVER CORP. |
| K884633 | ARISTA AND ORIENT SURGICAL GLOVES | Apr 20, 1989 | Substantially Equivalent | DURANTE INTL., INC. |
| K884622 | SURGICAL GLOVES | Mar 14, 1989 | Substantially Equivalent | GLOBE ENT., INC. |
| K890311 | KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) | Mar 03, 1989 | Substantially Equivalent | KOSAN FAR EAST ENT. LTD. |
| K884425 | GLOVE, SURGICAL | Feb 06, 1989 | Substantially Equivalent | MED-PAK CORP. |
| K883556 | LATEX SURGICAL GLOVE (NON STERILE) | Feb 03, 1989 | Substantially Equivalent | MAKINTECH CORP. |
| K882200 | STERILE & NON-STERILE SURGEONS GLOVES | Feb 03, 1989 | Substantially Equivalent | TAROKO ENT., LTD. |
| K890073 | MODERN LATEX STERILE SURGICAL GLOVES | Jan 24, 1989 | Substantially Equivalent | MODERN RUBBER CO., LTD. C/O WORLD TRADE SVC. |
| K884499 | LATEX SURGICAL GLOVES | Jan 09, 1989 | Substantially Equivalent | YULI CORP., INC. |
| K881664 | LATEX SURGICAL GLOVE | Jan 06, 1989 | Substantially Equivalent | LIEN CHANG RUBBER INDUSTRIAL CO., LTD. |
| K882431 | CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES | Dec 02, 1988 | Substantially Equivalent | CHARISE CHARLES, LTD. |
| K883466 | STERILE SURGICAL GLOVES | Nov 25, 1988 | Substantially Equivalent | CAL-AMERICAN EXPORTS, INC. |
| K882639 | PALMA | Nov 25, 1988 | Substantially Equivalent | KELSO IMPORTS |
| K882715 | STERILE SURGICAL LATEX GLOVES | Nov 08, 1988 | Substantially Equivalent | PLASTIC MATERIALS OF PUERTO RICO, INC. |
| K884030 | ERGO II, SURGICAL LATEX GLOVES | Nov 07, 1988 | Substantially Equivalent | ERGO INTL., ENT., INC. |
| K883824 | STERILE SURGICAL LATEX GLOVES | Oct 13, 1988 | Substantially Equivalent | INTL. TRADING VENTURES, INC. |
| K883736 | STERILE SURGEONS GLOVES | Oct 12, 1988 | Substantially Equivalent | MEDICAL MANUFACTURERS MARKETING CO. |
| K882595 | MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM | Oct 04, 1988 | Substantially Equivalent | MARATHON MANAGEMENT CO. |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent | ROSEBURG SA |
| K883244 | PRISTINE XTRA, SURGEON'S GLOVE | Aug 23, 1988 | Substantially Equivalent | JAPAN WORLD MEDICAL SUPPLY |
| K881374 | SURGEONS GLOVES | Aug 05, 1988 | Substantially Equivalent | INTERPRO INTL., INC. |
| K882381 | PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI | Jul 07, 1988 | Substantially Equivalent | PIONEERING TECHNOLOGIES, INC. |
| K880480 | DUNFORD SURGEON'S STERILE GLOVES | Jun 17, 1988 | Substantially Equivalent | PHILLIPPINE RADIANT C/O U.S. POLYMER INDUSTRIES |
| K881821 | STERILE SURGICAL LATEX GLOVE | Jun 01, 1988 | Substantially Equivalent | NCA MED INTL./NOBLE HOUSE, INC. |
| K881756 | STERILE SURGEONS GLOVES | Jun 01, 1988 | Substantially Equivalent | PACKAGING TECHNOLOGIES, INC. |
| K880446 | SAFESKIN STERILE SURGEONS GLOVES | Jun 01, 1988 | Substantially Equivalent | SAFESKIN CORP. |
| K881069 | DISPOSABLE STERILE LATEX SURGICAL GLOVES | Apr 05, 1988 | Substantially Equivalent | KOMIN TRADING CO. |
| K880535 | PROFECT SURGEONS' GLOVES | Apr 05, 1988 | Substantially Equivalent | NETWORK TRADING CORP. |
| K881191 | REGAL LATEX SURGICAL GLOVES | Apr 01, 1988 | Substantially Equivalent | MAXCARE, INC. |
| K880632 | PROTEQ SURGEON'S GLOVES | Mar 31, 1988 | Substantially Equivalent | STRATEGIC MATERIALS GROUP |
| K880035 | DAEWOO LATEX SURGICAL GLOVE | Mar 04, 1988 | Substantially Equivalent | CALIFORNIA ENT. |
| K872996 | NATURAL-TOUCH (TM) SURGEON'S GLOVE | Mar 04, 1988 | Substantially Equivalent | HANDS-ON PACKAGING LTD. |
| K875349 | STERILE SURGICAL NATURAL LATEX GLOVES | Feb 16, 1988 | Substantially Equivalent | MARAND PRODUCTS, INC. |
| K874539 | HI-TOUCH (TM) BRAND SURGICAL GLOVES | Dec 14, 1987 | Substantially Equivalent | APEX MEDICAL TECHNOLOGIES, INC. |
| K874099 | REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE | Dec 14, 1987 | Substantially Equivalent | BIOPRO, INC. |
| K864521 | ANGEL LATEX SURGICAL GLOVES | Dec 18, 1986 | Substantially Equivalent | KIM INTL. TRADING CO. |
| K864165 | MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES | Nov 17, 1986 | Substantially Equivalent | MBK MEDICAL GLOVES CO., LTD. |
| K864064 | LATEX SURGICAL GLOVES | Oct 30, 1986 | Substantially Equivalent | FUTUREMED DIV. OF FUTURE IMPEX CORP. |
| K861441 | NEUTRALON SURGICAL GLOVES | May 30, 1986 | Substantially Equivalent | SURGIKOS, INC. |
| K850635 | ANSELL NO POWDER SURGEON'S GLOVES | Jun 26, 1985 | Substantially Equivalent | ANSELL, INC. |
| K842884 | SURGEON'S GLOVES | Nov 29, 1984 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K844236 | PRISTINE | Nov 21, 1984 | Substantially Equivalent | MEDICAL DIMENSIONS |
| K843125 | PERRY DERMAGUARD SURGICAL GLOVES | Sep 25, 1984 | Substantially Equivalent | PERRY, DIV. |
| K831632 | MEDICAL RUBBER GLOVES-STERILE-SURGEONS | Jul 23, 1984 | Substantially Equivalent | TAGUM RUBBER INDUSTRIES, LTD. |
| K840343 | PDI PREPMASTER WET PACK VAGINAL-X21477 | Mar 27, 1984 | Substantially Equivalent | NICE-PAK PRODUCTS, INC. |
| K833976 | VANISH | Feb 04, 1984 | Substantially Equivalent | PARKE-DAVIS CO. |
| K832448 | TRIFLEX SURGEON'S GLOVES | Jan 27, 1984 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K833093 | VANISH II | Dec 12, 1983 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K831565 | MICRO-THIN SURGICAL GLOVE | Jul 19, 1983 | Substantially Equivalent | ANSELL, INC. |
| K823086 | DESERET SURGEON'S GLOVE ACCESSORY | Jan 17, 1983 | Substantially Equivalent | PARKE-DAVIS CO. |
| K820665 | DERMA PRENE | May 03, 1982 | Substantially Equivalent | ANSELL, INC. |
| K812421 | STERILE DISPOSABLE SURGICAL GLOVES | Feb 10, 1982 | Substantially Equivalent | INTERMARKET LATEX, INC. |
| K813565 | RADIATION STERILIZED SURGEON'S GLOVES | Jan 22, 1982 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K813088 | DESERET NEOLON SURGICAL GLOVES | Dec 14, 1981 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K812735 | CLOTH SURGICAL GLOVES | Nov 06, 1981 | Substantially Equivalent | MEDICAL SYNERGY |
| K811753 | SURGEON'S GLOVES | Sep 11, 1981 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K802641 | GAMMEX SURGICAL GLOVES | Dec 11, 1980 | Substantially Equivalent | ANSELL, INC. |
| K802027 | VIALON SURGEON'S GLOVES | Oct 10, 1980 | Substantially Equivalent | RIVEFAIN CORP. |
| K800152 | SURGIKOS NEUTRALON BR. SURGEON'S GLOVE | Feb 19, 1980 | Substantially Equivalent | SURGIKOS, INC. |
| K791843 | PONCY PAK | Dec 19, 1979 | Substantially Equivalent | PONCY, INC. |
| K781847 | LATEX, IN-HOUSE COMPOUNDED | Nov 03, 1978 | Substantially Equivalent | ARBROOK MFG. CORP. |
| K780419 | SUBCLAVIAN TRAY | Mar 27, 1978 | Substantially Equivalent | CONCORD LABORATORIES, INC. |
| K770704 | GLOVES, SURGEONS, LATEX | Jun 24, 1977 | Substantially Equivalent | TILLOTSON RUBBER CO., INC. |
| K770056 | GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE | Feb 25, 1977 | Substantially Equivalent | ARBROOK MFG. CORP. |
| K760912 | DRESSING CHANGE KIT | Dec 02, 1976 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K760560 | CATH CARE KIT | Nov 12, 1976 | Substantially Equivalent | WALPAK CO. |
| K760811 | GLOVE, SURGEON | Nov 03, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
| K760248 | GLOVES, APARTICULATE SURGICAL | Aug 09, 1976 | Substantially Equivalent | DEKNATEL, INC. |
| K760243 | GLOVES, STERILE LATEX SURGEON'S | Aug 03, 1976 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
FEI Numbers
This FDA classification entry is associated with 143 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 143 registration numbers. Click on an entry to view related FDA registrations.