VINYL POWDER FREE EXAMINATION GLOVE— 510(k) K091383

Name: FDA 510(k) clearance K091383
Creator: U.S. Food and Drug Administration
Published: 2009-07-22

Substantially Equivalent

Shun Tong Co., Ltd.

FDA 510(k) clearance K091383 for VINYL POWDER FREE EXAMINATION GLOVE, Substantially Equivalent on 2009-07-22. Applicant: Shun Tong Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shun Tong Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2009-05-11
Decision date: 2009-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinghua City, Jiangsu, CN

Download summary PDF View on FDA.gov ↗

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