AAMI4 Isolation Gown— 510(k) K214116

Name: FDA 510(k) clearance K214116
Creator: U.S. Food and Drug Administration
Published: 2022-10-11

Substantially Equivalent

Hubei Xinxin Non-Woven Co., Ltd.

FDA 510(k) clearance K214116 for AAMI4 Isolation Gown, Substantially Equivalent on 2022-10-11. Applicant: Hubei Xinxin Non-Woven Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hubei Xinxin Non-Woven Co., Ltd.
Product code: Code FYC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2021-12-30
Decision date: 2022-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiantao, CN

Download summary PDF View on FDA.gov ↗

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