Vinyl Powder Free Examination Glove— 510(k) K212011

Name: FDA 510(k) clearance K212011
Creator: U.S. Food and Drug Administration
Published: 2022-02-14

Substantially Equivalent

Top Glove Vietnam Company Limited

FDA 510(k) clearance K212011 for Vinyl Powder Free Examination Glove, Substantially Equivalent on 2022-02-14. Applicant: Top Glove Vietnam Company Limited. Device class: 1.

Clearance details

Applicant: Top Glove Vietnam Company Limited
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-06-28
Decision date: 2022-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bau Bang, VN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.