FDA 510(k) Application Details - K123749

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123749
Device Name	Polymer Patient Examination Glove
Applicant	KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 16632, 5 1/4 MILES, JALAN MERU KLANG SELANGOR DARUL EHSAN 41050 MY Other 510(k) Applications for this Company
Contact	CHO SOW FONG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2012
Decision Date	03/01/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review