ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)— 510(k) K142911

Name: FDA 510(k) clearance K142911
Creator: U.S. Food and Drug Administration
Published: 2015-04-10

Substantially Equivalent

Huailai ZM Plastic Products Co., Ltd.

FDA 510(k) clearance K142911 for ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), Substantially Equivalent on 2015-04-10. Applicant: Huailai ZM Plastic Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Huailai ZM Plastic Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2014-10-06
Decision date: 2015-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiakou, CN

Download summary PDF View on FDA.gov ↗

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