What is Non-Surgical Gown?
Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not 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 as much of the body as is appropriate to the task. As referenced in Figure 2, all areas of the non-surgical gownexcept bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown.
- The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.
- Surgical isolation gowns are used when there is a medium to high risk of contamination and need for larger critical zones than traditional surgical gowns.