Top Glove Corporation
Top Glove est le plus grand fabricant mondial de gants en caoutchouc, produisant des gants en nitrile, en latex, chirurgicaux, a…
Top Glove est le plus grand fabricant mondial de gants en caoutchouc, produisant des gants en nitrile, en latex, chirurgicaux et spécialisés dans 47 usines en Malaisie et en Thaïlande. L'entreprise fournit des gants d'examen, des gants pour salles blanches et des gants de protection industrielle aux hôpitaux, aux distributeurs et aux acheteurs industriels dans 195 pays. Propose des niveaux de prix de gros par volume avec une certification tierce selon les normes ASTM/EN.
- Type
- brand seeking distribution
- Location
- Shah Alam, Malaysia
- Founded
- 1991
- Website
- topglove.com
- Categories
- Équipements de sécurité et de protection, Fournitures médicales et de santé, Caoutchouc et matériaux composites
- Markets
- États-Unis, Allemagne, Royaume-Uni, Japon, Australie
Verified facts
- domain-registered (green), checked 2026-08-10 Domain registry record
- 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
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- registered-manufacturer (green), checked 2026-08-22 Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
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
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)