VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)— 510(k) K090513

Name: FDA 510(k) clearance K090513
Creator: U.S. Food and Drug Administration
Published: 2009-05-08

Substantially Equivalent

Shandong Huayue Glove Co., Ltd.

FDA 510(k) clearance K090513 for VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED), Substantially Equivalent on 2009-05-08. Applicant: Shandong Huayue Glove Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shandong Huayue Glove Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2009-02-26
Decision date: 2009-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangdian, Shandong, CN

Download summary PDF View on FDA.gov ↗

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