Surgical isolation gowns are used where the risk of infection is low to high and sensitive areas are more comprehensive than typical surgical robes. Surgical isolation robes, including operating robes, are governed by the FDA as a medical product of Class II, including a notice from 510(k) premarket. As seen in Figure 2, all parts of the working insulation gown other than bindings, cuffs, and hems are essential protective areas and fulfill the maximum degree of a protective liquid barrier for that gown. The liquid barrier protection of the seams must be the same as the rest of the coat. The cloth can also protect as much of the body as it is suitable to use the surgical insulation gown.
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