Surgical Gowns
Surgical gowns are tiered by the extent of protection and the corresponding environments where they should be worn. AAMI (The Association for the Advancement of Medical Instrumentation) and specifically, ANSI (American National Standards Institute)/AAMI PB70:2012 set forth the classification system (Levels 1-4), 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. Surgical gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Given the extreme shortage in gowns, they too have been the subject of much price gauging and fraud. There are no shortcuts in the diligence required to verify the manufacturer and the logistical supply chain up until delivery.
