Powder Free Vinyl Examination Gloves— 510(k) K211103

Name: FDA 510(k) clearance K211103
Creator: U.S. Food and Drug Administration
Published: 2021-11-04

Substantially Equivalent

Shanghai Shengda Medical Applications Co., Ltd.

FDA 510(k) clearance K211103 for Powder Free Vinyl Examination Gloves, Substantially Equivalent on 2021-11-04. Applicant: Shanghai Shengda Medical Applications Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai Shengda Medical Applications Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-04-13
Decision date: 2021-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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