FDA 510(k) Application Details - K091643

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K091643
Device Name	Patient Examination Glove, Specialty
Applicant	GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR KLANG, SELANG DARUL EHSAN 42100 MY Other 510(k) Applications for this Company
Contact	FOO KHON PU Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2009
Decision Date	11/02/2009
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