FDA 510(k) Application Details - K013443

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K013443
Device Name	Latex Patient Examination Glove
Applicant	MAXTER GLOVE MANUFACTURING SDN BHD LOT 607, JALAN HAJI ABDUL MANAN 41050 KLANG, SELANGOR 41050 MY Other 510(k) Applications for this Company
Contact	STANLEY THAI 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	10/17/2001
Decision Date	11/29/2001
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