FDA 510(k) Application Details - K100895

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K100895
Device Name	Latex Patient Examination Glove
Applicant	DIPPED PRODUCTS LIMITED 400 DEANS ROAD COLUMBO 10 LK Other 510(k) Applications for this Company
Contact	W.S.E.F. FERNANDO 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	03/31/2010
Decision Date	05/27/2011
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	Y
Expedited Review