FDA 510(k) Application Details - K990812

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K990812
Device Name	Latex Patient Examination Glove
Applicant	AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL BATANG KALI, SELANGOR 44300 MY Other 510(k) Applications for this Company
Contact	PACK LOON TANG 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	03/11/1999
Decision Date	05/04/1999
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