POWDER FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K102171

Name: FDA 510(k) clearance K102171
Creator: U.S. Food and Drug Administration
Published: 2010-11-16

Substantially Equivalent

Wuxi Bingfa Gainlite Gloves Cp., Ltd.

FDA 510(k) clearance K102171 for POWDER FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2010-11-16. Applicant: Wuxi Bingfa Gainlite Gloves Cp., Ltd.. Device class: 1.

Clearance details

Applicant: Wuxi Bingfa Gainlite Gloves Cp., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-08-02
Decision date: 2010-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pennington, NJ, US

Download summary PDF View on FDA.gov ↗

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