FDA 510(k) Application Details - K014230

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K014230
Device Name	Surgeon'S Gloves
Applicant	SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA SUNGAI BULOH, SELANGOR 47000 MY Other 510(k) Applications for this Company
Contact	STANLEY THAI 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	12/26/2001
Decision Date	03/13/2002
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