Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device. All areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated.  All seams must have the same liquid barrier protection as the rest of the gown.  Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.

In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:

Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases

Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery,  when pathogen resistance is needed or infectious diseases are suspected (non-airborne).

Regardless of how the product is named, when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels.