Cleared Traditional

K223401 - Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
(FDA 510(k) Clearance)

K223401 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital

Mar 2023

Decision

118d

Days

Class 2

Risk

K223401 is an FDA 510(k) clearance for the Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL), a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on March 7, 2023, 118 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	K223401 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 09, 2022
Decision Date	March 07, 2023
Days to Decision	118 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF