Disposable Vinyl Examination Gloves— 510(k) K203439

Name: FDA 510(k) clearance K203439
Creator: U.S. Food and Drug Administration
Published: 2021-02-26

Substantially Equivalent

Shandong Zhushi Pharmaceutical Group Co., Ltd.

FDA 510(k) clearance K203439 for Disposable Vinyl Examination Gloves, Substantially Equivalent on 2021-02-26. Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2020-11-23
Decision date: 2021-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heze, CN

Download summary PDF View on FDA.gov ↗

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