POWDERED VINYL EXAMINATION GLOVES— 510(k) K122100

Name: FDA 510(k) clearance K122100
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Wang Tong Xinghua Co., Ltd.

FDA 510(k) clearance K122100 for POWDERED VINYL EXAMINATION GLOVES, Substantially Equivalent on 2013-08-22. Applicant: Wang Tong Xinghua Co., Ltd.. Device class: 1.

Clearance details

Applicant: Wang Tong Xinghua Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-07-16
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinghua, CN

Download summary PDF View on FDA.gov ↗

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