Hartalega
Nitrile glove manufacturer with large-scale Malaysian plants.
Hartalega manufactures nitrile and latex examination gloves for healthcare and industrial protection markets. The company operates automated glove plants serving global medical distributors and OEM customers.
- Type
- Manufacturer
- Location
- Kuala Lumpur, Malaysia
- Founded
- 1988
- Website
- hartalega.com.my
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment
- Markets
- Malaysia, United States, Germany, Singapore
Verified facts
- web-presence-since (green), checked 2026-08-07 Internet Archive (Wayback)
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- places-goods-on-market (green), checked 2026-08-19 MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- fda-registered (green), checked 2026-08-06 FDA
- debarment-clear (green), checked 2026-08-06 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- fda-contract-manufacturer (green), checked 2026-08-06 FDA
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- 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)