FDA 510(k) Application Details - K213187

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213187
Device Name	Polymer Patient Examination Glove
Applicant	Fujian Chunhui Medical Supply Co., Ltd. No.179, Shanggeteng Ping, Shifang Village, Shifang County, Wuping Town Longyan City 364301 CN Other 510(k) Applications for this Company
Contact	Jing Cai Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	01/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review