FDA 510(k) Application Details - K123368

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123368
Device Name	Latex Patient Examination Glove
Applicant	HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA BESTARI JAYA SELANGOR 45600 MY Other 510(k) Applications for this Company
Contact	NURUL AISYAH KONG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2012
Decision Date	05/07/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review