Kossan Rubber Industries
Gloves, technical rubber products and cleanroom products.
Kossan Rubber Industries manufactures medical gloves, industrial gloves, technical rubber products and cleanroom products in Malaysia. Its products serve healthcare, infrastructure, automotive and industrial customers.
- Type
- Manufacturer
- Location
- Klang, Malaysia
- Founded
- 1979
- Website
- kossan.com.my
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment, Industrial Supplies, Rubber & Composite Products
- Markets
- Malaysia, United States, Germany, Singapore
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- debarment-clear (green), checked 2026-08-06 OpenSanctions
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)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)