FDA 510(k) Application Details - K110250

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K110250
Device Name	Latex Patient Examination Glove
Applicant	TOTAL GLOVES SDN BHD KAMUNTING INDUSTRIAL ESTATE KAMUNTING TAIPING, PERAK 34600 MY Other 510(k) Applications for this Company
Contact	OOI LOON SENG 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	01/28/2011
Decision Date	10/14/2011
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