FDA 510(k) Application Details - K162312

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K162312
Device Name	Polymer Patient Examination Glove
Applicant	SHEN WEI USA INC. 33278 CENTRAL AVE STE 102 UNION CITY, CA 94587 US Other 510(k) Applications for this Company
Contact	CHERYL BAILEY-KROLL 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	08/18/2016
Decision Date	07/25/2017
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