FDA 510(k) Application Details - K990901

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K990901
Device Name	Latex Patient Examination Glove
Applicant	APL PRODUCTS SDN. BHD. LOT 8961 & 8964 JALAN BENUAS AYER TAWAR,PERAK DARUL RIDZUAN 32400 MY Other 510(k) Applications for this Company
Contact	SON HONG LEE 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	03/18/1999
Decision Date	05/04/1999
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