FDA 510(k) Application Details - K151392

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K151392
Device Name	Surgeon'S Gloves
Applicant	TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2, INDUSTRIAL ZONE, KOTA BHARU 16100 MY Other 510(k) Applications for this Company
Contact	ROBERT HILL Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2015
Decision Date	09/18/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review