POWDERED LATEX SURGICAL GLOVE— 510(k) K062797

Name: FDA 510(k) clearance K062797
Creator: U.S. Food and Drug Administration
Published: 2007-04-11

Substantially Equivalent

Beijing Reagent Latex Products Co., Ltd.

FDA 510(k) clearance K062797 for POWDERED LATEX SURGICAL GLOVE, Substantially Equivalent on 2007-04-11. Applicant: Beijing Reagent Latex Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Beijing Reagent Latex Products Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2006-09-19
Decision date: 2007-04-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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