FDA 510(k) Application Details - K001047

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K001047
Device Name	Surgeon'S Gloves
Applicant	GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	03/31/2000
Decision Date	04/28/2000
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