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These standards are established by AAMI (The Association for the Advancement of Medical Instrumentation). Specifically, ANSI (American National Standards Institute)/AAMI PB70:2012 is the standard that establishes a classification system (Levels 1-4) for protective apparel used in health care facilities, including surgical gowns, based on liquid barrier performance using standardized test methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/ AAMI PB70:2012 as the standard by which all surgical gown manufacturers must abide.
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