POWDER FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K113837

Name: FDA 510(k) clearance K113837
Creator: U.S. Food and Drug Administration
Published: 2012-04-27

Substantially Equivalent

Hebei Changsheng Plastic Products Co., Ltd.

FDA 510(k) clearance K113837 for POWDER FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2012-04-27. Applicant: Hebei Changsheng Plastic Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hebei Changsheng Plastic Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2011-12-28
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xingtai, Hebei Province, CN

Download summary PDF View on FDA.gov ↗

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