Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the person wearing it from the transfer of microorganisms and body fluids. The protection is in a low or minimal risk medical situation. Non-surgical gowns are not to be worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination. Like surgical isolation gowns, non-surgical gowns should also cover a large portion of the body.
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