FDA 510(k) Application Details - K992679

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K992679
Device Name	Surgeon'S Gloves
Applicant	WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA PORT KLANG, SELANGOR, D.E. 42000 MY Other 510(k) Applications for this Company
Contact	CLAUDE COTTET 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	08/10/1999
Decision Date	10/21/1999
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