Brightway Holdings Sdn. Bhd.
KLANG, Selangor, MY
BRIGHTWAY HOLDINGS SDN. BHD. appears in FDA device records in KLANG, Selangor, MY. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Brightway Holdings Sdn. Bhd. between 1999 and 2022. The busiest year on record is 1999, with 9. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 9 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2006 | 2 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 5 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | |
| K163267 | NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | LZA | Substantially Equivalent | |
| K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K102880 | BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) | LZA | Substantially Equivalent | |
| K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | LZA | Substantially Equivalent | |
| K060658 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) | LYY | Substantially Equivalent | |
| K032940 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | |
| K032938 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | |
| K022878 | BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) | LZA | Substantially Equivalent | |
| K011728 | BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( | LYY | Substantially Equivalent | |
| K010856 | STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED | LYY | Substantially Equivalent | |
| K991940 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) | KGO | Substantially Equivalent | |
| K991939 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) | KGO | Substantially Equivalent | |
| K990876 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) | LZA | Substantially Equivalent | |
| K990878 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | |
| K990543 | BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) | LYY | Substantially Equivalent | |
| K990542 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | LZA | Substantially Equivalent | |
| K990541 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) | LZA | Substantially Equivalent | |
| K990540 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) | LYY | Substantially Equivalent | |
| K990539 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617444 | 1000153304 | BRIGHTWAY HOLDINGS SDN. BHD. | LOT 1559, JALAN ISTIMEWA,, KLANG, Selangor 42100 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain