Vinyl Exam Gloves, Powder Free, Clear— 510(k) K161390

Name: FDA 510(k) clearance K161390
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Substantially Equivalent

Zibo Hongchin Plastic and Rubber Co., Ltd.

FDA 510(k) clearance K161390 for Vinyl Exam Gloves, Powder Free, Clear, Substantially Equivalent on 2016-12-19. Applicant: Zibo Hongchin Plastic and Rubber Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Hongchin Plastic and Rubber Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2016-05-19
Decision date: 2016-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Download summary PDF View on FDA.gov ↗

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