Powder-Free White Vinyl Patient Examination Gloves— 510(k) K143346

Name: FDA 510(k) clearance K143346
Creator: U.S. Food and Drug Administration
Published: 2015-07-22

Substantially Equivalent

Zibo Changda Plastic Products Company, Limited

FDA 510(k) clearance K143346 for Powder-Free White Vinyl Patient Examination Gloves, Substantially Equivalent on 2015-07-22. Applicant: Zibo Changda Plastic Products Company, Limited. Device class: 1.

Clearance details

Applicant: Zibo Changda Plastic Products Company, Limited
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2014-11-21
Decision date: 2015-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Download summary PDF View on FDA.gov ↗

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