What classification do exam gloves and manual surgical instruments fall under?

Exam gloves and manual surgical instruments are classified as Class I devices. This classification pertains to items that are generally considered to be low risk and are subject to the least regulatory controls. Class I devices are often exempt from premarket notification, meaning they do not require extensive testing or approval by the FDA before they can be marketed, provided they meet certain criteria.

Gloves used for examination purposes are primarily designed to protect healthcare providers and patients from contamination and infection, thus fulfilling essential safety functions. Similarly, manual surgical instruments, which are used in various procedures, are critical for ensuring precision and safety in surgical settings. Since both of these types of equipment pose minimal risk when used as intended, they fit into the Class I category under the FDA classification system.

Understanding the classification helps pharmacy professionals comply with regulations regarding the handling, distribution, and sale of medical devices, ensuring patient safety and adherence to legal requirements.