Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by FDA, industry, the standards community, and health care professionals.