FDA 510(k) Application Details - K073299

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K073299
Device Name	Latex Patient Examination Glove
Applicant	BETELCARE SDN BHD LOT 3342, JALAN KERETAPI LAMA 7 1/2 MI OFF JALAN KAPAR SELANGOR, DARUL EHSAN 42200 MY Other 510(k) Applications for this Company
Contact	KENG BENG SIAH 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	11/23/2007
Decision Date	03/05/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review