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Surgical Isolation Gowns

What is Surgical Isolation Gowns

Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns.  Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  As referenced in Figure 2, all areas of the surgical isolation gown except 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.  Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.

Figure 2 – Critical Zones for Surgical Isolation Gowns and Non-Surgical Gowns
  • 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.

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