FDA 510(k) Applications Submitted by SMART GLOVE CORP. SDN BHD

FDA 510(k) Number Submission Date Device Name Applicant
K060724 03/17/2006 POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) SMART GLOVE CORP. SDN BHD
K060726 03/17/2006 POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) SMART GLOVE CORP. SDN BHD
K063627 12/06/2006 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) SMART GLOVE CORP. 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
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
K061724 06/19/2006 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) SMART GLOVE CORP. 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
K033683 11/24/2003 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR SMART GLOVE CORP. SDN BHD
K974870 12/29/1997 LATEX EXAMINATION GLOVE POWDER FREE SMART GLOVE CORP. 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
K050598 03/09/2005 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) SMART GLOVE CORP. SDN BHD
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
K991624 05/11/1999 POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES SMART GLOVE CORP. 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
K021521 05/10/2002 STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES SMART GLOVE CORP. SDN BHD
K021013 03/29/2002 SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) SMART GLOVE CORP. SDN BHD
K012853 08/24/2001 SMART GLOVE STERILE NITRILE EXAM GLOVE SMART GLOVE CORP. SDN BHD
K013727 11/09/2001 STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G SMART GLOVE CORP. SDN BHD
K011066 04/09/2001 STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) SMART GLOVE CORP. SDN BHD


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