Cleared Traditional

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

K223411 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital
Jan 2023
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K223411 is an FDA 510(k) clearance for the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL), a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 4, 2023, 56 days after receiving the submission on November 9, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K223411 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2022
Decision Date January 04, 2023
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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