FDA 510(k) Application Details - K972801

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K972801
Device Name	Latex Patient Examination Glove
Applicant	ALLIANCE RUBBER PRODUCTS SDN. BHD. 878, JALAN BANDAR BARU, SUNGEI KECIL, NIBONG TEBAL PULAU PINANG 14300 MY Other 510(k) Applications for this Company
Contact	CHUA HOOI KOON 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	07/28/1997
Decision Date	10/21/1997
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