FDA 510(k) Application Details - K061551

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K061551
Device Name	Latex Patient Examination Glove
Applicant	MEDIPURE CORPORATION (M) SDN. BHD. LOT 12 MEDAN TASEK TASEK INDUSTRAIL ESTATE IPOH, PERAK 31400 MY Other 510(k) Applications for this Company
Contact	TERENCE LIM SIN KOOI 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	06/05/2006
Decision Date	08/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review