FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
K Number: K172923
·
Decision Apr 26, 2018
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
17
Review Days
213
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Basic Information
- Device Name
- Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
- K Number
- K172923
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Top Glove Sdn. Bhd.
- Date Received
- September 25, 2017
- Decision Date
- April 26, 2018
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Top Glove Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | Sep 3, 2020 | Substantially Equivalent |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | Jun 5, 2020 | Substantially Equivalent |
| 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 |
| K122999 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Nov 30, 2012 | Substantially Equivalent |
| K023974 | ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES | Feb 13, 2003 | Substantially Equivalent |
| K021855 | TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) | Aug 5, 2002 | Substantially Equivalent |
| K993664 | SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES | Jan 11, 2000 | Substantially Equivalent |
| K993605 | PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES | Dec 20, 1999 | Substantially Equivalent |
| K993452 | GREEN POWDERED LATEX EXAMINATION GLOVES | Dec 20, 1999 | Substantially Equivalent |
| K993680 | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE | Dec 13, 1999 | Substantially Equivalent |