FDA 510(k) Application Details - K192933

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K192933
Device Name	Surgeon'S Gloves
Applicant	Emerson & Co. Srl Piazza Della Vittoria 10 Genoa 16121 IT Other 510(k) Applications for this Company
Contact	Laura Figliomeni 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	10/17/2019
Decision Date	01/13/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review