FDA 510(k) Application Details - K990488

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K990488
Device Name	Latex Patient Examination Glove
Applicant	TERANG NUSA SDN BHD LOT E4(4), JALAN 8 PENGKALAN CHEPA II FTZ KOTA BHARU, KELANTAN 16100 MY Other 510(k) Applications for this Company
Contact	CHIN GUAN LOW 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	02/16/1999
Decision Date	05/28/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review