FDA 510(k) Application Details - K071323

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K071323
Device Name	Latex Patient Examination Glove
Applicant	QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT TAIPING, PERAK 34700 MY Other 510(k) Applications for this Company
Contact	SEAH B HOON 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	05/10/2007
Decision Date	06/22/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review