FDA 510(k) Application Details - K222620

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K222620
Device Name	Surgeon'S Gloves
Applicant	Suzhou Colour-way New Material Co., Ltd. No. 20, Anmin Road, Huangdai Town, Xiangcheng District Suzhou 215152 CN Other 510(k) Applications for this Company
Contact	Yongping Xu Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2022
Decision Date	03/23/2023
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