FDA 510(k) Application Details - K991950

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K991950
Device Name	Surgeon'S Gloves
Applicant	LAGLOVE (M) SDN. BHD. JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS, 43000 KAJANG SELANGOR DARUL EHSAN MALA MG Other 510(k) Applications for this Company
Contact	G. BASKARAN 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	06/09/1999
Decision Date	08/12/1999
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