FDA 510(k) Application Details - K123760

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123760
Device Name	Polymer Patient Examination Glove
Applicant	ASSURGUARD SDN. BHD. 82F, JALAN PULASAN KLANG SELANGOR DARUL EHSAN 41000 MY Other 510(k) Applications for this Company
Contact	LIM HUI GUAN 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	12/07/2012
Decision Date	01/28/2013
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