FDA 510(k) Application Details - K171375

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K171375
Device Name	Surgeon'S Gloves
Applicant	Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 US Other 510(k) Applications for this Company
Contact	Robert Mahler 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	05/10/2017
Decision Date	02/06/2018
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