Top Glove Corporation
Top Glove es el mayor fabricante de guantes de goma del mundo y produce nitrilo, látex, quirúrgicos,…
Top Glove es el mayor fabricante de guantes de goma del mundo y produce guantes de nitrilo, látex, quirúrgicos y especiales en 47 fábricas en Malasia y Tailandia. La empresa suministra guantes de examen, guantes para salas blancas y guantes de protección industrial a hospitales, distribuidores y compradores industriales en 195 países. Ofrece niveles de precios al por mayor por volumen con certificación de terceros según las normas ASTM/EN.
- Type
- brand seeking distribution
- Location
- Shah Alam, Malaysia
- Founded
- 1991
- Website
- topglove.com
- Categories
- Equipos de seguridad y protección, Suministros médicos y sanitarios, Caucho y materiales compuestos
- Markets
- Estados Unidos, Alemania, Reino Unido, Japón, Australia
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)