Disposable Surgical Isolation Gown— 510(k) K212422

Name: FDA 510(k) clearance K212422
Creator: U.S. Food and Drug Administration
Published: 2022-04-29

Substantially Equivalent

Crown Name Disposable Hygiene Products Fty., Ltd.

FDA 510(k) clearance K212422 for Disposable Surgical Isolation Gown, Substantially Equivalent on 2022-04-29. Applicant: Crown Name Disposable Hygiene Products Fty., Ltd.. Device class: 2.

Clearance details

Applicant: Crown Name Disposable Hygiene Products Fty., Ltd.
Product code: Code FYC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2021-08-04
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

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