FDA 510(k) Application Details - K222128

Device Classification Name	More FDA Info for this Device
510(K) Number	K222128
Device Name	Protective Gown AAMI Level 4
Applicant	Kenpax International Limited Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, KowLoon Hong Kong 999077 CN Other 510(k) Applications for this Company
Contact	Solomon Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2022
Decision Date	08/08/2023
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