POWDER FREE VINYL PATIENT EXAMINATION GLOVE— 510(k) K101137

Name: FDA 510(k) clearance K101137
Creator: U.S. Food and Drug Administration
Published: 2010-06-22

Substantially Equivalent

Hongze Plastic Technology Co., Ltd.

FDA 510(k) clearance K101137 for POWDER FREE VINYL PATIENT EXAMINATION GLOVE, Substantially Equivalent on 2010-06-22. Applicant: Hongze Plastic Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hongze Plastic Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-04-22
Decision date: 2010-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

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