FDA 510(k) Application Details - K123328

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K123328
Device Name	Polymer Patient Examination Glove
Applicant	NITRILIST GLOVES MANUFACTURING SDN BHD PT 197, KAWASAN PERINDUSTRIAN DIOH KUALA PILAH 72000 MY Other 510(k) Applications for this Company
Contact	LAU SIONG HUT 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	10/22/2012
Decision Date	01/18/2013
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