Brightway Holdings Sdn. Bhd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Brightway Holdings Sdn. Bhd.” (first 1999, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 59 days. Since 2017 the median was 198 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 236 |
| 2017 | 5 | 157 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 509 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Brightway Holdings Sdn. Bhd. took a median 198 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 13 | 13 |
| LYY | Latex Patient Examination Glove | 8 | 8 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (24)
Most recent Brightway Holdings Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2022-11-02 | 509 |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | LZA | 2017-07-14 | 129 |
| K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2017-04-21 | 249 |
| K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | LZC | 2017-03-31 | 239 |
| K163267 | NITRILE EXAMINATION GLOVE | LZA | 2017-03-24 | 123 |
| K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | LZA | 2017-01-05 | 157 |
| K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | 2016-12-21 | 236 |
| K102880 | BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) | LZA | 2010-11-19 | 50 |
| K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | LZA | 2006-06-09 | 114 |
| K060658 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) | LYY | 2006-04-10 | 54 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Brightway Holdings Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Brightway Gloves Pvt. , Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brightway Holdings Sdn. Bhd.?
FDA lists 24 510(k) clearances under the applicant name “Brightway Holdings Sdn. Bhd.” (first 1999, latest 2022), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Brightway Holdings Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brightway Holdings Sdn. Bhd. is 59 days. Since 2017: 198 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Brightway Holdings Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 13); LYY (Latex Patient Examination Glove, 8); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 24 Brightway Holdings Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Brightway Holdings Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.