Brightway Holdings
Sarung tangan nitril, sarung tangan lateks, sarung tangan ruang bersih, dan sarung tangan medis.
Brightway Holdings memproduksi sarung tangan nitril, sarung tangan lateks, sarung tangan ruang bersih, dan sarung tangan medis dari operasinya di Klang. Perusahaan ini memasok pembeli layanan kesehatan, distributor APD, pembeli keselamatan industri, atau pelanggan ekspor di seluruh pasar utamanya yang terdaftar.
- Type
- Manufacturer
- Location
- Klang, Malaysia
- Founded
- 1988
- Website
- brightwayholdings.com
- Categories
- Perlengkapan Medis & Kesehatan, Peralatan Keselamatan & Pelindung, Produk Karet & Komposit
- Markets
- Malaysia, Singapura, Thailand, Australia
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-07 Domain registry record
- web-presence-since (green), checked 2026-08-07 Internet Archive (Wayback)
- 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)