FDA 510(k) Application Details - K032467

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K032467
Device Name	Surgeon'S Gloves
Applicant	MAXTER GLOVE MANUFACTURING SDN BHD 6TH MILES OFF JALAN MERU KLANG SELANGOR 41050 MY Other 510(k) Applications for this Company
Contact	PRISCILLA WEE Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2003
Decision Date	10/10/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review