Brightway Holdings Sdn. Bhd.

FDA Regulatory Profile

Brightway Holdings Sdn. Bhd. has 0 FDA recalls, 0 inspections, 24 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Nov 2, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances24Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy…Nov 2, 2022
K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsJul 14, 2017
K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH…Apr 21, 2017
K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMMar 31, 2017
K163267NITRILE EXAMINATION GLOVEMar 24, 2017
K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)Jan 5, 2017
K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With…Dec 21, 2016
K102880BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)Nov 19, 2010
K060402BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)Jun 9, 2006
K060658BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)Apr 10, 2006
K032938BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER…Nov 20, 2003
K032940BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER…Nov 20, 2003
K022878BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)Sep 17, 2002
K011728BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50…Jul 9, 2001
K010856STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50…Jun 6, 2001
K991940BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)Jul 12, 1999
K991939BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)Jul 1, 1999
K990876BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)Jun 23, 1999
K990878BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)May 21, 1999
K990541BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)Apr 9, 1999