Rugby Laboratories

Rugby Laboratories specializes in two primary device categories: basic male condoms made from Hevea latex and skin-cover adhesive strips that are non-antimicrobial. Both products are branded under the RUGBY name. These devices are designed for barrier protection, serving both medical and general-use purposes.

Rugby Laboratories is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s device classification system (Class I or Class II). This means compliance with U.S. regulatory requirements applies to its products, such as registration and listing in the FDA’s Unique Device Identifier (UDI) database.

Rugby Laboratories’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices in circulation.

Rugby Laboratories’ devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.