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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: