FDA NEWS
U.S. FDA News: information, analysis and news for executives in industries regulated by the U.S. Food and Drug Administration.
FDA Prior Notice: no prior notice, inaccurate prior notice, or untimely prior notice, are inadequate, and will result in refusal of admission.
Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) Premarket Notification.