FDA 510(k) Application Details - K983146

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K983146
Device Name	Polymer Patient Examination Glove
Applicant	ALLIANCE RUBBER PRODUCTS SDN. BHD. PERINDUSTRIAN BUKIT PANCHOR 14300 NIBONG TEBAL PULAU PINANG 52446-U 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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1998
Decision Date	12/07/1998
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