There are a few guidelines(AAMI, FDA, AORN) established to help healthcare facilities decide which gown is appropriate protection for their staff, but which guidelines should be followed? Before you choose your gowns, know the organizations and what their guidelines cover. Here as below is FDA guidelines for disposable gowns
According to FDA guidelines, surgical gowns are classified as Class 2 Medical Devices, they are regulated by the US Food and Drug Administration (FDA)
In December 2015, the FDA issued new, more stringent guidance3 for pre-market verification of surgical gowns. Before performance claims are made on labeling and published materials, surgical gowns are thoroughly reviewed by the FDA to ensure that:
The gown complies with the claimed liquid barrier protection (ANSI/AAMI PB70 or equivalent standard)
Performance test data backs up that claim
Drawings are clearly labeled with barrier protection level and dimensions/location of critical and non-critical zones
Sample labeling clearly identifies the level of liquid barrier protection (per ANSI/AAMI PB70) as well as directions and indications for use.
