SHIELD Scientific B.V.

SHIELD Scientific B.V. specializes in single-use examination gloves and skin protection barriers. Their product range includes nitrile and latex gloves, often formulated without powder (powder-free touch or PFT variants) and designed for chemical resistance (e.g., CHEM™). These devices are intended for medical, laboratory, and industrial applications, with variations in texture and size to suit specific use cases.

SHIELD Scientific B.V. is based in the Netherlands, which places its devices under EU medical device regulations. This means the company must comply with EU standards for manufacturing, labeling, and post-market surveillance, ensuring their products meet the necessary requirements for market placement within the European Economic Area.

SHIELD Scientific B.V.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry tracks device information, including manufacturer details, classifications, and regulatory status, ensuring transparency and compliance with EU medical device legislation.

All of SHIELD Scientific B.V.’s listed devices fall under Class I classification in the EU. This classification applies to low-risk medical devices like single-use gloves and skin protection barriers, which are deemed to pose minimal risk to patients and users when used as intended. Class I devices typically require conformity assessment procedures such as self-certification or a notified body review.