FDA 510(k) Application Details - K062797

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K062797
Device Name	Surgeon'S Gloves
Applicant	BEIJING REAGENT LATEX PRODUCTS CO., LTD. 1676 VILLAGE GREEN CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	RYAN BARR 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	09/19/2006
Decision Date	04/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review