Disposable Surgical Gown (G4003)— 510(k) K221977

Name: FDA 510(k) clearance K221977
Creator: U.S. Food and Drug Administration
Published: 2022-10-20

Substantially Equivalent

Xiantao Topmed Nonwoven Protective Products Co., Ltd.

FDA 510(k) clearance K221977 for Disposable Surgical Gown (G4003), Substantially Equivalent on 2022-10-20. Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Product code: Code FYA
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2022-07-05
Decision date: 2022-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiantao, CN

Download summary PDF View on FDA.gov ↗

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