FDA 510(k) Application Details - K170198

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K170198
Device Name	Surgeon'S Gloves
Applicant	Cardinal Health, Inc. 1500 Waukegan Road Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Megan Middaugh 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	01/23/2017
Decision Date	06/15/2017
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