FDA 510(k) Application Details - K211953

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K211953
Device Name	Surgeon'S Gloves
Applicant	Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd No. 316 National road, Xinju, Changshan Town, Jinxian County Nanchang 331724 CN Other 510(k) Applications for this Company
Contact	Jenny Huang 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	06/23/2021
Decision Date	05/25/2022
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