The Food and Drug Administration (FDA) is the U.S. Government
agency that oversees most medical products, foods, and
cosmetics. FDA regulates medical devices by evaluating and
approving/clearing the product to ensure they are safe and
effective. PPE, including masks/respirators, medical gloves, and
surgical gowns, which is intended for use in preventing or
treating disease is considered a medical device and is given a
classification. The device/product classification is assigned to
one of three regulatory classes based on the level of control
necessary to assure the safety and effectiveness of the device.
Face masks are considered a Class II (intermediate risk) device.
In 1983, the Centers for Disease Control (CDC) made the first
recommendations for the prevention of exposure to blood and body
fluids through the use of universal precautions. In December
2003, the CDC published its “Guidelines for Infection Control in
Dental Health-Care Settings”. Although CDC has no regulatory
authority, its recommendations a