FDA 510(k) Applications Submitted by Brightway Holdings Sdn. Bhd.

FDA 510(k) Number Submission Date Device Name Applicant
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.
K990539 02/22/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD.
K990540 02/22/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) BRIGHTWAY HOLDINGS SDN. BHD.
K990541 02/22/1999 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) 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.
K170686 03/07/2017 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs Brightway Holdings Sdn. Bhd.
K990876 03/16/1999 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) BRIGHTWAY HOLDINGS SDN. BHD.
K990878 03/16/1999 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS 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.
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.
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.
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.
K102880 09/30/2010 BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) BRIGHTWAY HOLDINGS SDN. BHD.


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