Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)— 510(k) K211667

Name: FDA 510(k) clearance K211667
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

Substantially Equivalent

Changzhou Universal Medical Equipment Co., Ltd.

FDA 510(k) clearance K211667 for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile), Substantially Equivalent on 2021-09-23. Applicant: Changzhou Universal Medical Equipment Co., Ltd.. Device class: 1.

Clearance details

Applicant: Changzhou Universal Medical Equipment Co., Ltd.
Product code: Code LAZ
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 2021-06-01
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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