Tag Archives: FDA Surgical Isolation Gowns

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 … Continue reading

Documentation, Gown