FDA 510(k) Application Details - K992558

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K992558
Device Name	Polymer Patient Examination Glove
Applicant	RIVERSTONE RESOURCES SDN. BHD. LOT 21909, NO.5, LORONG HELAN HINDIK KEPONG BARU INDUST. EST KEPONG BARU, KUALA LUMPUR 52100 MY Other 510(k) Applications for this Company
Contact	C.M. CHONG 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	07/30/1999
Decision Date	09/27/1999
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