FDA 510(k) Application Details - K171279

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K171279
Device Name	Surgeon'S Gloves
Applicant	Top Glove SDN BHD Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang 41050 MY Other 510(k) Applications for this Company
Contact	Noor Akilah Bt Saidin 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	05/01/2017
Decision Date	10/12/2017
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