POWDER FREE VINYL EXAMINATION GLOVES— 510(k) K122377

Name: FDA 510(k) clearance K122377
Creator: U.S. Food and Drug Administration
Published: 2014-04-11

Substantially Equivalent

Shu Tong Xinghua Co., Ltd.

FDA 510(k) clearance K122377 for POWDER FREE VINYL EXAMINATION GLOVES, Substantially Equivalent on 2014-04-11. Applicant: Shu Tong Xinghua Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shu Tong Xinghua Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-07-23
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinghua, CN

Download summary PDF View on FDA.gov ↗

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