Cleared Traditional

Disposable Surgical Gown

K214088 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Apr 2022
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K214088 is an FDA 510(k) clearance for the Disposable Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on April 12, 2022, 105 days after receiving the submission on December 28, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K214088 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2021
Decision Date April 12, 2022
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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