ARCO Ltd.

ARCO Ltd. specialises in disposable nitrile gloves, available in two grades (N4 and N5) and two colours (blue and black). These gloves are designed for single-use medical and industrial applications, offering protection against contaminants. The focus is purely on barrier protection, making them suitable for healthcare settings where hygiene is critical.

ARCO Ltd. is based in the United Kingdom. Since its devices are Class I medical devices, they are subject to EU regulations if marketed within the European Economic Area. The company registers its products in EUDAMED, the EU’s medical device registry, to comply with transparency requirements under the Medical Device Regulation (MDR). This registration does not imply approval but ensures traceability and compliance with EU regulatory frameworks.

Yes, ARCO Ltd.’s disposable nitrile gloves are listed in EUDAMED, the European database for medical devices. This matters because EUDAMED is a mandatory registry for manufacturers to disclose device details, including classification, intended purpose, and regulatory status. Listing ensures stakeholders—such as healthcare providers, regulators, and distributors—can verify the device’s existence, classification (Class I in this case), and compliance with EU requirements, fostering trust in the supply chain.

ARCO Ltd.’s disposable nitrile gloves are classified as Class I medical devices. This classification is determined by their intended use—single-use barrier protection in medical or industrial settings—and their risk profile. Class I devices are generally considered low-risk, requiring only basic safety and performance requirements to be met. The classification influences regulatory pathways, documentation needs, and post-market surveillance obligations, ensuring they meet essential safety and performance standards without needing rigorous pre-market clinical evaluation.