FDA 510(k) Application Details - K060858

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K060858
Device Name	Latex Patient Examination Glove
Applicant	HIGH MOMENTUM SDN BHD LOT 4960, JALAN TERATAI BATU 6 OFF JALAN MERU KLANG, SELANGOR DARUL ESHSAN 41050 MY Other 510(k) Applications for this Company
Contact	HUE K FAH 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	03/29/2006
Decision Date	06/08/2006
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