VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)— 510(k) K083600

Name: FDA 510(k) clearance K083600
Creator: U.S. Food and Drug Administration
Published: 2009-02-19

Substantially Equivalent

Quantum Co., Ltd.

FDA 510(k) clearance K083600 for VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED), Substantially Equivalent on 2009-02-19. 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: 2009-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shandong, CN

Download summary PDF View on FDA.gov ↗

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