FDA 510(k) Application Details - K190077

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K190077
Device Name	Surgeon'S Gloves
Applicant	Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross, 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	01/16/2019
Decision Date	05/24/2019
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