Brightway Holdings
Nitrile gloves, latex gloves, cleanroom gloves and medical gloves.
Brightway Holdings manufactures nitrile gloves, latex gloves, cleanroom gloves and medical gloves from its Klang operations. The company supplies healthcare buyers, PPE distributors, industrial safety buyers or export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Klang, Malaysia
- Founded
- 1988
- Website
- brightwayholdings.com
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment, Rubber & Composite Products
- Markets
- Malaysia, Singapore, Thailand, Australia
Verified facts
- domain-registered (green), checked 2026-08-07 Domain registry record
- web-presence-since (green), checked 2026-08-07 Internet Archive (Wayback)
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- fda-registered (green), checked 2026-08-07 FDA
- debarment-clear (green), checked 2026-08-07 OpenSanctions
- sanctions-clear (green), checked 2026-08-07 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)