FDA 510(k) Application Details - K083156

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K083156
Device Name	Polymer Patient Examination Glove
Applicant	GIGA-DRIVE SDN, BHD 17A JALAN DATO HAJI MEGAT KHAS TAMAN BANDAR UTAMA IPOH, PERAK 31400 MY Other 510(k) Applications for this Company
Contact	IAN NG TZE CHEU 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	10/24/2008
Decision Date	05/08/2009
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