FDA 510(k) Application Details - K213168

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213168
Device Name	Polymer Patient Examination Glove
Applicant	Shandong Huiwosheng Health Technology Co.,Ltd 50m East Of Chaoyang Road, Zhanqian Street, Linyi Chemical Industrial Park, Linzi Town Dezhou 250000 CN Other 510(k) Applications for this Company
Contact	Haitao Wu 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	09/28/2021
Decision Date	01/11/2022
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