Data / Medical devices / Malaysia / Brightway Holdings Sdn. Bhd.
Brightway Holdings Sdn. Bhd.: FDA-registered device maker in KLANG, Selangor, Malaysia, 29 510(k) clearances
Brightway Holdings Sdn. Bhd. is registered with the FDA (registration 9617444) in KLANG, Selangor, Malaysia. It lists 4 device types. The FDA files 29 510(k) clearances under its listings, the newest dated November 2, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9617444
- FEI number
- 1000153304
- Address
- Lot 1559, Jalan Istimewa, Batu Belah, KLANG, Selangor, Malaysia, 42100
- Owner or operator
- BRIGHTWAY HOLDINGS SDN. BHD. (9036471)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- BRIGHTWAY BRAND, CTI International, Diamond M Latex Examination Powder Free Gloves, SMC BLUE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 2, 2022 | K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| July 14, 2017 | K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 21, 2017 | K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| March 31, 2017 | K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| March 24, 2017 | K163267 | NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| January 5, 2017 | K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| December 21, 2016 | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| November 19, 2010 | K102880 | BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| June 9, 2006 | K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 10, 2006 | K060658 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| November 20, 2003 | K032940 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| November 20, 2003 | K032938 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| September 17, 2002 | K022878 | BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| July 9, 2001 | K011728 | BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| June 6, 2001 | K010856 | STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| October 20, 2000 | K994281 | BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) | LZA | Substantially Equivalent | Biopro (M) Sdn Bhd | accessdata.fda.gov |
| July 26, 1999 | K992020 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) | KGO | Substantially Equivalent | Brightsway Holdings Sdn Bhd | accessdata.fda.gov |
| July 23, 1999 | K992021 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) | KGO | Substantially Equivalent | Brightsway Holdings Sdn Bhd | accessdata.fda.gov |
| July 12, 1999 | K991940 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) | KGO | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| July 1, 1999 | K991939 | BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) | KGO | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| June 23, 1999 | K991752 | BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | Brightsway Holdings Sdn Bhd | accessdata.fda.gov |
| June 23, 1999 | K991750 | BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN | LYY | Substantially Equivalent | Brightsway Holdings Sdn Bhd | accessdata.fda.gov |
| June 23, 1999 | K990876 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| May 21, 1999 | K990878 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990543 | BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990542 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990541 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990540 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 9, 1999 | K990539 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Surgeon'S Gloves
Updated November 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.