Brightway Holdings Sdn. Bhd.
MalaysiaFDA 510(k) applicant, unverified FDA FEI 1000153304
- Devices
- 24
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Brightway Holdings Sdn. Bhd. makes
Brightway Holdings produces examination and surgical gloves made from nitrile and latex materials. Their products include powdered and powder-free variants, with some designed for use with chemotherapy drugs and others tested for low protein extractables. The portfolio also features sterile and non-sterile gloves in various colors, including purple, blue, black, and grey.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States, and their products appear in the FDA’s 510(k) registry.
Catalogue
Search and filter all 24 devicesCompany details
- FDA FEI number
- 1000153304
- Address
- LOT 1559, JALAN ISTIMEWA,, KLANG, Selangor
Frequently asked questions
How many devices does Brightway Holdings Sdn. Bhd. have in the registry?
The registry currently lists 24 devices for Brightway Holdings Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brightway Holdings Sdn. Bhd.'s devices?
Among its 24 most recently registered devices, Brightway Holdings Sdn. Bhd. has devices listed in FDA 510(k) (24 devices).
What risk classes do Brightway Holdings Sdn. Bhd.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Brightway Holdings Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Brightway Holdings Sdn. Bhd. in the registry?
The most recently registered devices listed for Brightway Holdings Sdn. Bhd. include BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED), BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) and Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs.