FDA 510(k) Application Details - K012479

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K012479
Device Name	Surgeon'S Gloves
Applicant	SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR KLANG SELANGOR 42100 MY Other 510(k) Applications for this Company
Contact	FOO KHON PU 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	08/02/2001
Decision Date	09/26/2001
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