SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR— 510(k) K132201

Name: FDA 510(k) clearance K132201
Creator: U.S. Food and Drug Administration
Published: 2013-11-27

Substantially Equivalent

Zibo Intco Medical Products Co., Ltd.

FDA 510(k) clearance K132201 for SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR, Substantially Equivalent on 2013-11-27. Applicant: Zibo Intco Medical Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Intco Medical Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2013-07-16
Decision date: 2013-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino, CA, US

Download summary PDF View on FDA.gov ↗

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