FDA 510(k) Application Details - K180221

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K180221
Device Name	Surgeon'S Gloves
Applicant	Smart Glove Corporation Sdn.Bhd Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang 42100 MY Other 510(k) Applications for this Company
Contact	Foo Khon Pu 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	01/25/2018
Decision Date	08/08/2018
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