Supermax
Rubber gloves and contact lenses from Malaysia.
Supermax manufactures disposable gloves and has expanded into contact lens manufacturing under Malaysian brands. The company supplies medical, industrial and optical distribution channels worldwide.
- Type
- Manufacturer
- Location
- Sungai Buloh, Malaysia
- Founded
- 1987
- Website
- supermax.com.my
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment, Eyewear & Sunglasses, Rubber & Composite Products
- Markets
- Malaysia, United States, Germany, Singapore
Verified facts
- certificate-page-on-site (amber), checked 2026-08-12 Company's own certification page
- fda-registered (green), checked 2026-08-12 FDA
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- 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)
- Sunglasses and protective eyewear are personal protective equipment in the EU: CE marking under Regulation (EU) 2016/425 is required. European Commission (PPE)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)