Unigloves (UK) Limited

Unigloves (UK) Limited manufactures single-use, disposable gloves known as Derma Shield. These gloves are designed to protect against skin irritation and contamination, particularly in healthcare and industrial environments where prolonged contact with liquids, chemicals, or abrasive materials may occur. The focus is on maintaining skin barrier integrity during use.

Unigloves (UK) Limited is based in the United Kingdom. While the company’s location influences its regulatory framework—such as compliance with UK and EU standards—the specific classification and authorisation of its devices depend on their risk level and intended use, not the manufacturer’s country alone. In this case, the company’s products fall under EU MDR classification.

Unigloves (UK) Limited’s Derma Shield gloves are classified as Class I devices under the EU Medical Device Regulation (MDR). This classification is determined by their low-risk profile, as they are non-invasive and intended for short-term, single-use protection against skin exposure. Class I devices typically require less stringent regulatory scrutiny than higher-risk categories.

Yes, Unigloves (UK) Limited’s devices are registered in the eudamed database, which is the EU’s official registry for medical devices. Listing in eudamed ensures transparency and compliance with EU MDR requirements, allowing healthcare professionals and regulators to verify the manufacturer’s details and device information. This registration is mandatory for all medical devices marketed within the EU.