In the United States, medical gowns are medical devices regulated by the FDA. Surgical isolation gowns are regulated by the FDA as a that require a 510(k) premarket notification, but non-surgical gowns are Class I devices exempt from premarket review. Surgical gowns only require protection of the front of the body due to the controlled nature of surgical procedures, while surgical isolation gowns and non-surgical gowns require protection over nearly the entire gown. During the Ebola crisis of 2014, the WHO published a rapid advice guideline on PPE coveralls.