FDA 510(k) Application Details - K063524

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K063524
Device Name	Polymer Patient Examination Glove
Applicant	HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH KUALA PILAH, NEGERI SEMBILAN 72000 MY Other 510(k) Applications for this Company
Contact	KENNY HOE 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	11/22/2006
Decision Date	01/23/2007
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