FDA 510(k) Application Details - K063776

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K063776
Device Name	Latex Patient Examination Glove
Applicant	BRIGHT ELEMENT SDN BHD NO 5, JALAN USJ 3B/2 SUBANG JAYA, SELANGOR 47610 MY Other 510(k) Applications for this Company
Contact	SEOW LAW AUDIE 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	12/21/2006
Decision Date	03/02/2007
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