FDA 510(k) Application Details - K152719

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K152719
Device Name	Vinyl Patient Examination Glove
Applicant	XINFU MEDICAL PRODUCTS CO., LTD. EAST OF LIPINGTUO, LUANNAN COUNTY TANGSHAN CITY 063502 CN Other 510(k) Applications for this Company
Contact	XIE WENXING Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2015
Decision Date	03/01/2016
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