FDA 510(k) Application Details - K001094

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K001094
Device Name	Latex Patient Examination Glove
Applicant	JB STAR SDN BHD 3A JALAN CEKOR, TAMAN SRI AMAR JOHOR BARUE, JOHOR 81100 MY Other 510(k) Applications for this Company
Contact	LOOI CHIN SWEE 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	04/04/2000
Decision Date	04/28/2000
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