FDA issues draft guidance on requirements for surgical gowns

Editor's Note

The Food and Drug Administration has issued a draft guidance to describe its premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns used in health care settings.

In the past, a number of terms have been used to refer to gowns intended for use in health care settings, and some gown manufacturers were unsure about whether their gowns were Class I or Class II and whether they had to submit a 510(k) application for their products. This draft guidance clarifies parameters that determine whether a gown should be classified as a Class II medical device and thus require premarket notification.

The FDA proposes that any apparel claiming to provide ANSI/AAMI PB70 Level 3 or 4 protection, which corresponds to moderate or high-level barrier protection, is considered a Class II medical device and must demonstrate the liquid barrier performance defined in the PB70 standard. Any gown labeled as a “surgical gown,” or one “intended for use during sterile procedures” falls into this category.

Comments will be received on this draft guidance until August 31, 2015.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this draft guidance to describe the Agency's premarket regulatory requirements and...