POWDER-FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K082648

Name: FDA 510(k) clearance K082648
Creator: U.S. Food and Drug Administration
Published: 2009-09-25

Substantially Equivalent

Tangshan Dar Plastic & Rubber Products Co. , Ltd.

FDA 510(k) clearance K082648 for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2009-09-25. Applicant: Tangshan Dar Plastic & Rubber Products Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Tangshan Dar Plastic & Rubber Products Co. , Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2008-09-11
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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