Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs— 510(k) K220491

Name: FDA 510(k) clearance K220491
Creator: U.S. Food and Drug Administration
Published: 2022-05-14

Substantially Equivalent

Hainan Asther Medical Equipment Co., Ltd.

FDA 510(k) clearance K220491 for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2022-05-14. Applicant: Hainan Asther Medical Equipment Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hainan Asther Medical Equipment Co., Ltd.
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2022-02-22
Decision date: 2022-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengmai, CN

Download summary PDF View on FDA.gov ↗

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