FDA 510(k) Applications Submitted by G BASKARAN

FDA 510(k) Number Submission Date Device Name Applicant
K990285 01/29/1999 LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) LAGLOVE (M) SDN. BHD.
K010860 03/22/2001 LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) LAGLOVE (M) SDN. BHD.
K010861 03/22/2001 LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) LAGLOVE (M) SDN. BHD.
K092499 08/14/2009 LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) LAGLOVE (M) SDN. BHD.
K093193 10/13/2009 LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) LA GLOVE (M) SDN. BHD.
K093335 10/26/2009 LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) LAGLOVE (M) SDN. BHD.
K990268 01/28/1999 LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD.
K990270 01/28/1999 LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD.
K990420 02/10/1999 LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD.
K990415 02/10/1999 LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) LAGLOVE (M) SDN. BHD.
K060402 02/15/2006 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) BRIGHTWAY HOLDINGS SDN. BHD.
K060658 02/15/2006 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) BRIGHTWAY HOLDINGS SDN. BHD.
K990542 02/22/1999 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) BRIGHTWAY HOLDINGS SDN. BHD.
K990543 02/22/1999 BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K990541 02/22/1999 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K990540 02/22/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) BRIGHTWAY HOLDINGS SDN. BHD.
K990539 02/22/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K170686 03/07/2017 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs Brightway Holdings Sdn. Bhd.
K990883 03/16/1999 LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) LAGLOVE (M) SDN. BHD.
K990882 03/16/1999 LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) LAGLOVE (M) SDN. BHD.
K990878 03/16/1999 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K990876 03/16/1999 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) BRIGHTWAY HOLDINGS SDN. BHD.
K010863 03/22/2001 LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) LAGLOVE (M) SDN. BHD.
K010856 03/22/2001 STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED BRIGHTWAY HOLDINGS SDN. BHD.
K161215 04/29/2016 Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs BRIGHTWAY HOLDINGS SDN BHD
K991748 05/24/1999 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G LAGLOVE (M) SDN. BHD.
K991749 05/24/1999 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE LAGLOVE (M) SDN. BHD.
K991750 05/24/1999 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN BRIGHTSWAY HOLDINGS SDN BHD
K991752 05/24/1999 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE BRIGHTSWAY HOLDINGS SDN BHD
K011728 06/04/2001 BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( BRIGHTWAY HOLDINGS SDN. BHD.
K991939 06/09/1999 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K991940 06/09/1999 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) BRIGHTWAY HOLDINGS SDN. BHD.
K991949 06/09/1999 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) LAGLOVE (M) SDN. BHD.
K991950 06/09/1999 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) LAGLOVE (M) SDN. BHD.
K211816 06/11/2021 Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Brightway Holdings Sdn. Bhd.
K992018 06/16/1999 LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) LAGLOVE (M) SDN. BHD.
K992019 06/16/1999 LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) LAGLOVE (M) SDN. BHD.
K992020 06/16/1999 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) BRIGHTSWAY HOLDINGS SDN BHD
K992021 06/16/1999 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) BRIGHTSWAY HOLDINGS SDN BHD
K162146 08/01/2016 Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) BRIGHTWAY HOLDINGS SDN BHD.
K162186 08/04/2016 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM BRIGHTWAY HOLDINGS SDN BHD
K092498 08/14/2009 LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) LAGLOVE (M) SDN. BHD.
K162294 08/15/2016 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS BRIGHTWAY HOLDINGS SDN BHD.
K022878 08/30/2002 BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) BRIGHTWAY HOLDINGS SDN. BHD.
K032938 09/22/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER BRIGHTWAY HOLDINGS SDN. BHD.
K032940 09/22/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE BRIGHTWAY HOLDINGS SDN. BHD.
K042618 09/27/2004 LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) LAGLOVE (M) SDN. BHD.
K163267 11/21/2016 NITRILE EXAMINATION GLOVE BRIGHTWAY HOLDINGS SDN BHD


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