FDA 510(k) Application Details - K160675

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K160675
Device Name	Vinyl Patient Examination Glove
Applicant	KAIXING PLASTIC PRODUCTS CO., LITD. 1101 TANGGANG RD LUANNAN COUNTY Tangshan CN Other 510(k) Applications for this Company
Contact	Dan ny 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	03/10/2016
Decision Date	08/02/2016
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