Top Glove Corporation
Top Glove adalah produsen sarung tangan karet terbesar di dunia, memproduksi nitril, lateks, bedah,…
Top Glove adalah produsen sarung tangan karet terbesar di dunia, memproduksi sarung tangan nitril, lateks, bedah, dan khusus di 47 pabrik di Malaysia dan Thailand. Perusahaan ini memasok sarung tangan pemeriksaan, sarung tangan ruang bersih, dan sarung tangan pelindung industri ke rumah sakit, distributor, dan pembeli industri di 195 negara. Menawarkan tingkatan harga grosir berdasarkan volume dengan sertifikasi pihak ketiga sesuai standar ASTM/EN.
- Type
- Manufacturer
- Location
- Shah Alam, Malaysia
- Founded
- 1991
- Website
- topglove.com
- Categories
- Peralatan Keselamatan & Pelindung, Perlengkapan Medis & Kesehatan, Produk Karet & Komposit
- Markets
- Amerika Serikat, Jerman, Inggris Raya, Jepang, Australia
Verified facts
- debarment-clear (green), checked 2026-08-10 OpenSanctions
- sanctions-clear (green), checked 2026-08-10 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-10 Mail server of the company domain
- domain-registered (green), checked 2026-08-10 Domain registry record
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- 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)