FDA 510(k) Application Details - K150414

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K150414
Device Name	Polymer Patient Examination Glove
Applicant	INDUSTRIAL CLOTHINGS (PVT) LTD D17, SEETHAWAKA EXPORT PROCESSING ZONE AVISSAWELLA 10700 LK Other 510(k) Applications for this Company
Contact	S.N. HARI 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	02/18/2015
Decision Date	06/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review