Investigation of the Barrier Performance of Disposable Isolation Gowns.

The study findings underscore the need for improved processes surrounding activities such as premarket testing and post-market evaluation of gowns according to standardized test methods by third party laboratories. This study also supports the recent FDA guidance document that clarified the characteristics of isolation gowns considered to be class II and subject to FDA premarket review. Infection preventionists, hospital purchasers, and safety professionals should seek isolation gowns demonstrating conformance to industry standards from manufacturers.