FDA 510(k) Application Details - K221819

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K221819
Device Name	Gown, Surgical
Applicant	Winner Medical Co., Ltd. Winner Industrial Park, No.660 Bulong Road, Longhua District Guangdong 515109 CN Other 510(k) Applications for this Company
Contact	Mingni Liu Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2022
Decision Date	09/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review