FDA 510(k) Application Details - K984147

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K984147
Device Name	Latex Patient Examination Glove
Applicant	LOVYTEX SDN BHD LOT #8, JALAN SUASA TELOK PANGLIMA GARANG SELANGOR 42500 MY Other 510(k) Applications for this Company
Contact	M.G. DESAI 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	11/19/1998
Decision Date	01/20/1999
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