FDA Draft Guidance Addresses Claims Regarding Protection of Gowns against Liquids

The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry and FDA staff regarding gowns intended for use in healthcare settings, according to a notice published June 30, 2015, in the Federal Register. FDA issued the guidance to describe its premarket regulatory requirements and the performance testing needed to support claims regarding how effectively the gowns form a barrier against liquids. In 1988, FDA issued a final rule that classified surgical gowns and surgical masks as class II devices subject to premarket review and classified surgical apparel other than surgical gowns and surgical masks as class I devices also subject to premarket review. In 2000, FDA issued a final rule that exempted surgical apparel other than surgical gowns and surgical masks from premarket review, subject to certain limitations. Since the original 1988 final rule, many terms have been used to refer to gowns intended for use in healthcare settings, including surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.