Disposable Ultra Reinforced Surgical Gown— 510(k) K173847

Name: FDA 510(k) clearance K173847
Creator: U.S. Food and Drug Administration
Published: 2019-01-16

Substantially Equivalent

Xiantao Rayxin Medical Products Co., Ltd.

FDA 510(k) clearance K173847 for Disposable Ultra Reinforced Surgical Gown, Substantially Equivalent on 2019-01-16. Applicant: Xiantao Rayxin Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiantao Rayxin Medical Products Co., Ltd.
Product code: Code FYA
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2017-12-19
Decision date: 2019-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiantao, CN

Download summary PDF View on FDA.gov ↗

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