Top Glove Corporation
A Top Glove é a maior fabricante mundial de luvas de borracha, produzindo nitrila, látex, cirúrgicas,…
A Top Glove é a maior fabricante mundial de luvas de borracha, produzindo luvas de nitrila, látex, cirúrgicas e especiais em 47 fábricas na Malásia e na Tailândia. A empresa fornece luvas de exame, luvas para salas limpas e luvas de proteção industrial para hospitais, distribuidores e compradores industriais em 195 países. Oferece níveis de preços de atacado por volume com certificação de terceiros de acordo com os padrões ASTM/EN.
- Type
- Manufacturer
- Location
- Shah Alam, Malaysia
- Founded
- 1991
- Website
- topglove.com
- Categories
- Equipamentos de segurança e proteção, Suprimentos médicos e de saúde, Borracha e materiais compostos
- Markets
- Estados Unidos, Alemanha, Reino Unido, Japão, Austrália
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)