Knowledge · Latex-free materials
Latex-free materials in medical devices
Polyisoprene, polyurethane and nitrile as alternatives to natural rubber latex.
Latex-free materials are standard in the medical device field: natural rubber latex can trigger type I allergies (proteins) and type IV reactions (additives). Polyisoprene, polyurethane and nitrile are the established alternatives for gloves and elastic moulded parts — each with their own properties, advantages and labelling obligations.
Material comparison
| Material | Property | Typical use |
|---|---|---|
| Natural rubber latex | Very elastic, high tensile strength, proteins as allergen potential | Classic gloves and elastic moulded parts |
| Polyisoprene | Synthetic, latex-protein-free, latex-like elasticity | Gloves and elastic parts for allergy sufferers |
| Polyurethane | Thinner, less elastic, hypoallergenic, oxidation-stable | Thin films and coatings |
| Nitrile | Chemical-resistant, high puncture resistance, no protein potential | Examination gloves, occupational safety |
Labelling
Annex I of the EU MDR (requirement 23.2) requires labelling of devices containing natural rubber latex (e.g. “contains natural rubber latex”). “Latex-free” is only permissible if truly free of latex — documented in the technical documentation.
Frequently asked questions
Are latex-free gloves equally safe?
Polyisoprene reaches latex level in elasticity and tensile strength; nitrile is more chemical-resistant but less elastic. All must pass the standard tests applicable to their intended use.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.