FDA 510(k) Applications Submitted by NURUL AISYAH KONG

FDA 510(k) Number Submission Date Device Name Applicant
K140050 01/09/2014 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE HARTALEGA SDN BHD
K120336 02/03/2012 NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U HARTALEGA SDN BHD
K140890 04/08/2014 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) HARTALEGA NGC SDN. BHD.
K052177 08/10/2005 POWDER FREE STERILE LATEX SURGICAL GLOVES HARTALEGA SDN BHD
K123368 11/01/2012 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT HARTALEGA SDN BHD
K002593 08/21/2000 POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM HARTALEGA SDN BHD
K063046 10/04/2006 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) HARTALEGA SDN BHD
K112976 10/06/2011 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM HARTALEGA SND. BHD.
K050277 02/07/2005 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) HARTALEGA SDN BHD
K140610 03/10/2014 NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) HARTALEGA NGC SDN. BHD.
K132006 07/01/2013 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) HARTALEGA SDN BHD
K133956 12/23/2013 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN HARTALEGA SDN BHD
K130473 02/22/2013 NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) HARTALEGA SDN BHD
K110758 03/18/2011 NITRILE POWDER FREE EXAMINATION GLOVES HARTALEGA SDN BHD
K091652 06/09/2009 NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS HARTALEGA SDN BHD
K071910 07/11/2007 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) HARTALEGA SDN BHD
K133953 12/23/2013 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M HARTALEGA SDN BHD


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