FDA 510(k) Application Details - K140989

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K140989
Device Name	Surgeon'S Gloves
Applicant	HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD 853 DORCHESTER LN, UNITB NEW MILFORD, NJ 07646 US Other 510(k) Applications for this Company
Contact	CHARLES SHEN 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	04/17/2014
Decision Date	12/22/2014
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