Top Glove Corporation
Top Glove is the world's largest rubber glove manufacturer, producing nitrile, latex, surgical, a…
Top Glove is the world's largest rubber glove manufacturer, producing nitrile, latex, surgical, and specialty gloves at 47 factories in Malaysia and Thailand. The company supplies examination gloves, cleanroom gloves, and industrial protective gloves to hospitals, distributors, and industrial buyers in 195 countries. Offers wholesale price tiers by volume with third-party certification to ASTM/EN standards.
- Type
- Manufacturer
- Location
- Shah Alam, Malaysia
- Founded
- 1991
- Website
- topglove.com
- Categories
- Safety & Protective Equipment, Medical & Healthcare Supplies, Rubber & Composite Products
- Markets
- United States, Germany, United Kingdom, Japan, 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)