Disposable Surgical Gown

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·        Â·        A surgical gown is regulated by the FDA as aClass II medical device that requires a 510(k) premarket notification.  Asurgical gown is a personal protective garment intended to be worn by healthcare personnel during surgical procedures to protect both the patient andhealth care personnel from the transfer of microorganisms, body fluids, andparticulate matter. Because of the controlled nature of surgical procedures,critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the bodyfrom top of shoulders to knees and the arms from the wrist cuff to above theelbow.  Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as a surgical gown.