FDA 510(k) Application Details - K012853

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K012853
Device Name	Polymer Patient Examination Glove
Applicant	SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR KLANG SELANGOR 42100 MY Other 510(k) Applications for this Company
Contact	NG YEW SOON Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2001
Decision Date	11/16/2001
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