FDA 510(k) Application Details - K111139

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K111139
Device Name	Surgeon'S Gloves
Applicant	ANSELL HEALTHCARE PRODUCTS, INC. 555 ZANG STREET SUITE 100 LAKEWOOD, CO 80228 US Other 510(k) Applications for this Company
Contact	NEIL BURRIS Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2011
Decision Date	09/02/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review