FDA 510(k) Application Details - K101103

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K101103
Device Name	Surgeon'S Gloves
Applicant	BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN SG CHOH RAWANG, SELANGOR 48000 MY Other 510(k) Applications for this Company
Contact	EFFENDI TENANG 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	04/20/2010
Decision Date	07/16/2010
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