Hartalega
Nhà sản xuất găng tay nitrile với các nhà máy quy mô lớn ở Malaysia.
Hartalega sản xuất găng tay kiểm tra nitrile và latex cho thị trường bảo hộ công nghiệp và chăm sóc sức khỏe. Công ty vận hành các nhà máy sản xuất găng tay tự động phục vụ các nhà phân phối y tế toàn cầu và khách hàng OEM.
- Type
- brand seeking distribution
- Location
- Kuala Lumpur, Malaysia
- Founded
- 1988
- Website
- hartalega.com.my
- Categories
- Vật tư y tế và chăm sóc sức khỏe, Thiết bị an toàn và bảo hộ
- Markets
- Malaysia, Hoa Kỳ, Đức, Singapore
Verified facts
- web-presence-since (green), checked 2026-08-07 Internet Archive (Wayback)
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- certificate-page-on-site (amber), checked 2026-08-30 Company's own certification page
- 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)