FDA 510(k) Application Details - K201592

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K201592
Device Name	Surgeon'S Gloves
Applicant	Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Padmini Sahoo 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	06/12/2020
Decision Date	09/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review