FDA 510(k) Application Details - K992358

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K992358
Device Name	Latex Patient Examination Glove
Applicant	BIOPRO (M) SDN BHD LOT14, PT.4204 LINGKARN SULTN HISHAMUDDIN, NO. PRT. INDU. PORT KLANG 42000 MY Other 510(k) Applications for this Company
Contact	JIM LALE Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/1999
Decision Date	09/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review