Sterile gloves sold in the United States must meet standards set by which regulatory agency?

Sterile gloves sold in the United States must meet standards set by the Food and Drug Administration (FDA). The FDA is responsible for regulating medical devices and ensuring they are safe and effective for public use. This includes overseeing the manufacturing practices and the quality of products such as sterile gloves, which are essential in preventing contamination and ensuring safety in healthcare settings.

The FDA establishes the classification of medical devices, including sterile gloves, and sets specific requirements for their performance, labeling, and production processes. This regulatory oversight helps ensure that healthcare professionals and patients receive products that meet stringent quality and safety standards.

Other agencies, while important in their own right, focus on different aspects of health and safety. For example, the Centers for Disease Control and Prevention (CDC) provides guidelines for infection control practices but does not have regulatory authority over medical devices. The Occupational Safety and Health Administration (OSHA) sets standards to protect workers but does not regulate the safety of sterile medical devices themselves. The Environmental Protection Agency (EPA) deals primarily with environmental protection issues and does not oversee medical device standards.