FDA regulates a surgical gown as a Class II medical element that needs a 510(k) premarket notification. A surgical gown is a protective garment for personal use. Health care personnel wear these. It protects both the health care personnel and the patient from the transfer of body fluids, microorganisms, and particulate elements. Due to the maintained nature of surgical processes, national standards have described the critical zones of protection.
The critical zones comprise the chest from the scapula to knees and sleeves from cuff to above the elbow. Doctors and nurses can use surgical gowns to fight any risk level. All surgical gowns should have the label as a surgical gown. People should use the surgical isolation gowns when there is a chance of a medium to high risk of contamination. Also, the are useful for larger critical zones that the traditional surgical gowns can’t assure. FDA regulates the isolation gowns just as the as a Class II medical device. It requires a 510(k) premarket notification.
All areas of the surgical isolation gown apart from the bindings, cuffs, and hems are the critical zones of protection. These should meet the highest liquid barrier protection level for which the dress is useful. All seams should have similar liquid barrier protection just like the rest of the dress. Also, the fabric of the surgical isolation gown should cover the body according to the use.