FDA 510(k) Application Details - K143477

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K143477
Device Name	Polymer Patient Examination Glove
Applicant	PRIMUS GLOVES PVT LIMITED PLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD COCHIN 682037 IN Other 510(k) Applications for this Company
Contact	JOSE PAUL M 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	12/05/2014
Decision Date	04/14/2016
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