FDA 510(k) Applications Submitted by Foo Khon Pu

FDA 510(k) Number Submission Date Device Name Applicant
K070096 01/10/2007 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR GX CORPORATION SDN BHD
K080066 01/10/2008 VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) GX CORPORATION SDN BHD
K050122 01/19/2005 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) SMART GLOVE CORP. SDN BHD
K090412 02/18/2009 POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). GX CORPORATION SDN BHD
K071119 04/20/2007 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) GX CORPORATION SDN BHD
K091147 04/20/2009 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) SMART GLOVE CORP. SDN BHD
K081466 05/27/2008 STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE SMART GLOVE CORP. SDN BHD
K091643 06/04/2009 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD
K061724 06/19/2006 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) SMART GLOVE CORP. SDN BHD
K041848 07/08/2004 POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR PT. SMART GLOVE INDONESIA
K092072 07/08/2009 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE GX CORPORATION SDN BHD
K082370 08/18/2008 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) SMART GLOVE CORP. SDN BHD
K012856 08/24/2001 STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G SMART GLOVE CORP. SDN BHD
K022814 08/26/2002 MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) PT. SMART GLOVE INDONESIA
K022815 08/26/2002 MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX PT. SMART GLOVE INDONESIA
K033683 11/24/2003 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR SMART GLOVE CORP. SDN BHD
K083717 12/15/2008 POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK GX CORPORATION SDN BHD
K974870 12/29/1997 LATEX EXAMINATION GLOVE POWDER FREE SMART GLOVE CORP. SDN BHD
K070097 01/10/2007 POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR GX CORPORATION SDN BHD
K080937 04/02/2008 POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE GX CORPORATION SDN BHD
K091151 04/20/2009 POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN GX CORPORATION SDN BHD
K081315 05/09/2008 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) GX CORPORATION SDN BHD
K002568 08/18/2000 POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) SMART GLOVE CORP. SDN BHD
K974907 12/31/1997 NITRILE PRE-POWDERED EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD
K030112 01/13/2003 POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB PT. SMART GLOVE INDONESIA
K030284 01/27/2003 POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) PT. SMARTGLOVE INDONESIA
K030406 02/07/2003 NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR PT. SMART GLOVE INDONESIA
K050598 03/09/2005 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) SMART GLOVE CORP. SDN BHD
K040791 03/29/2004 POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) PT. SMART GLOVE INDONESIA
K040792 03/29/2004 POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) PT. SMART GLOVE INDONESIA
K981347 04/10/1998 SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM SMART GLOVE CORP. SDN BHD
K981348 04/10/1998 SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD
K981349 04/10/1998 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD
K071170 04/27/2007 POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL SMART GLOVE CORP. SDN BHD
K971665 05/06/1997 SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES SJ MEDICAL PRODUCTS (M) SDN BHD
K971666 05/06/1997 SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES SJ MEDICAL PRODUCTS (M) SDN BHD
K991624 05/11/1999 POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD
K091851 06/22/2009 STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD
K092200 07/22/2009 POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) GX CORPORATION SDN BHD
K012479 08/02/2001 STERILE NITRILE SURGICAL GLOVES (POWDERED) SMART GLOVE CORP. SDN BHD
K022818 08/26/2002 MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR SMART GLOVE CORP. SDN BHD
K974557 12/05/1997 SMARTTEX SMART GLOVE CORP. SDN BHD
K180221 01/25/2018 Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd
K182089 08/02/2018 Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs Platinum Glove Industries Sdn Bhd
K971403 04/15/1997 SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE SJ MEDICAL PRODUCTS (M) SDN BHD


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