Disposable Synthetic Vinyl Nitrile Examination Glove— 510(k) K211354

Name: FDA 510(k) clearance K211354
Creator: U.S. Food and Drug Administration
Published: 2021-08-08

Substantially Equivalent

Jiangsu Cureguard Glove Co., Ltd.

FDA 510(k) clearance K211354 for Disposable Synthetic Vinyl Nitrile Examination Glove, Substantially Equivalent on 2021-08-08. Applicant: Jiangsu Cureguard Glove Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Cureguard Glove Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-05-03
Decision date: 2021-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suqian, CN

Download summary PDF View on FDA.gov ↗

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