FDA 510(k) Application Details - K083337

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K083337
Device Name	Latex Patient Examination Glove
Applicant	TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE KOTA BHARU, KELANTAN 16100 MY Other 510(k) Applications for this Company
Contact	ROBERT HILL 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	11/12/2008
Decision Date	01/27/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review