Which is an example of a class III medical device?

Class III medical devices are characterized as those that usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. These devices typically require premarket approval due to their intricacy and the risks associated with their use.

Implantable pacemakers are a prime example of a Class III medical device because they are vital for controlling heart rhythms and directly impacting patients' lives. The rigorous testing and regulatory scrutiny that these devices undergo reflect their importance in ensuring safety and effectiveness given their critical function in maintaining heart health.

In contrast, bandages, surgical gloves, and X-ray machines fall under different classes based on their intended use and risk profiles. Bandages and surgical gloves are generally classified as Class I devices, which have lower risk and are subject to less regulatory control. X-ray machines, while more complex, typically fall into Class II, which still necessitates a moderate level of oversight but not as stringent as that required for Class III devices. Thus, the unique characteristics and regulatory measures required for implantable pacemakers distinctly categorize them as a Class III medical device.