FDA 510(k) Application Details - K202090

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K202090
Device Name	Surgeon'S Gloves
Applicant	Molnlycke Health Care, US LLC 5445 Triangle Parkway, Suite 400 Peachtree Corners, GA 30092 US Other 510(k) Applications for this Company
Contact	Leonard Stewart 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	07/28/2020
Decision Date	11/22/2020
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