Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves— 510(k) K171279
Substantially EquivalentTop Glove Sdn. Bhd.
FDA 510(k) clearance K171279 for Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves, Substantially Equivalent on 2017-10-12. Applicant: Top Glove Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Top Glove Sdn. Bhd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, MY
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More clearances from Top Glove Sdn. Bhd.
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- K193150 — Latex Examination Powder Free Glove, Aloe Vera
- K172923 — Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
- K122999 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.