FDA 510(k) Application Details - K013953

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K013953
Device Name	Latex Patient Examination Glove
Applicant	SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA SUNGAI BULOH, SELANGOR 47000 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	11/30/2001
Decision Date	02/26/2002
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