DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES— 510(k) K031171

Name: FDA 510(k) clearance K031171
Creator: U.S. Food and Drug Administration
Published: 2003-05-23

Substantially Equivalent

Synmertex Co, Ltd.

FDA 510(k) clearance K031171 for DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, Substantially Equivalent on 2003-05-23. Applicant: Synmertex Co, Ltd.. Device class: 1.

Clearance details

Applicant: Synmertex Co, Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-04-14
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rowland Heights, CA, US

Download summary PDF View on FDA.gov ↗

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