FDA 510(k) Application Details - K072197

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K072197
Device Name	Patient Examination Glove, Specialty
Applicant	METACURE SURGICAL GLOVES SDN BHD NO. 1, JLN 203, OFF JALAN TANDANG PETALING JAYA 46050 MY Other 510(k) Applications for this Company
Contact	AZMAN ISMAIL Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2007
Decision Date	03/12/2008
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