# Brightway Holdings Sdn. Bhd.

- Location (FDA's records): Klang, Selangor Darul Ehsan, MY
- FDA decisions: 24 (1999–2022): 24 510(k) clearances
- Product codes: LZA (13), LYY (8), KGO (2), LZC (1)
- 510(k) review time since 2016: median 236 days, against 124 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kimberly-Clark Corp.: 3 (https://510kreport.com/company/kimberly-clark)
- Safeskin Corp.: 1 (https://510kreport.com/company/safeskin)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)
- Primus Gloves Pvt Limited: 1 (https://510kreport.com/company/primus-gloves-pvt)

## Firms that cite its devices most
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Yty Industry (Manjung) Sdn Bhd: 1 (https://510kreport.com/company/yty-industry-manjung-sdn-bhd)

## Its most-cited devices
- K170686: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs (2017), cited by 1
- K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (2016), cited by 1

## Recent decisions
- K211816: Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Nov 2, 2022)
- K170686: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs (Jul 14, 2017)
- K162294: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs (Apr 21, 2017)
- K162186: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim (Mar 31, 2017)
- K163267: Nitrile Examination Glove (Mar 24, 2017)
- K162146: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) (Jan 5, 2017)
- K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (Dec 21, 2016)
- K102880: Brightway TM Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color) (Nov 19, 2010)

Source page: https://510kreport.com/company/brightway-holdings-sdn-bhd