FDA 510(k) Application Details - K151528

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K151528
Device Name	Polymer Patient Examination Glove
Applicant	GALLANT QUALITY SDN. BHD. LOT 1874, JALAN KAMPUNG DEW TAIPING 34700 MY Other 510(k) Applications for this Company
Contact	SUMATHI SARAVANA SAMI 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	06/08/2015
Decision Date	10/09/2015
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