FDA 510(k) Application Details - K213832

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K213832
Device Name	Gown, Isolation, Surgical
Applicant	Hubei Xinxin Non-woven Co., Ltd. Taizihu Industrial Park, Pengchang Town Xiantao 433018 CN Other 510(k) Applications for this Company
Contact	Nicole Jin Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2021
Decision Date	05/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review