SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE— 510(k) K083931

Name: FDA 510(k) clearance K083931
Creator: U.S. Food and Drug Administration
Published: 2009-04-27

Substantially Equivalent

Quantum Co., Ltd.

FDA 510(k) clearance K083931 for SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE, Substantially Equivalent on 2009-04-27. Applicant: Quantum Co., Ltd.. Device class: 1.

Clearance details

Applicant: Quantum Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2008-12-05
Decision date: 2009-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shandong, CN

Download summary PDF View on FDA.gov ↗

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