FDA 510(k) Application Details - K991689

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991689
Device Name	Latex Patient Examination Glove
Applicant	USG HEALTHGUARD SDN BHD LOT 2756 JALAN KEMPAS LAMA (OFF 8 MILES JALAN SKUDAI) SKUDAI, JOHOR BAHRU, JOHOR 81300 MY Other 510(k) Applications for this Company
Contact	TOH CHEE YEONG 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	05/18/1999
Decision Date	06/24/1999
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