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Surgical Gowns

What is Surgical Gown?

A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate 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 body from top of shoulders to knees and the arms from the wrist cuff to above the elbow.  Surgical gowns can be used for any risk level (Levels 1-4).  All surgical gowns must be labeled as a surgical gown.

Figure 1 – Critical Zones for Surgical Gowns

  • The entire front of the gown (areas A, B, and C) is required to have a barrier performance of at least level 1.
  • The critical zone compromises at least areas A and B.
  • The back of the surgical gown (area D) may be nonprotective.
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