FDA 510(k) Application Details - K072614

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K072614
Device Name	Latex Patient Examination Glove
Applicant	MATANG MFG. SDN. BHD. LOT 10, KAWASAN PERINDUSTRIAN SERKAM, MUKIM SERKAM MERLIMAU, MELAKA 77300 MY Other 510(k) Applications for this Company
Contact	LESLIE LEONG 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	09/17/2007
Decision Date	04/15/2008
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