What are the different classifications mean for the surgical gown?

For personal protective equipment or PPE, you must choose the appropriate equipment based on your situation. An important component of an effective PPE strategy is a surgical gown also known as the sterile surgical gown or disposable surgical gown, which is designed to prevent cross-contamination and protect the wearer's skin and clothing from liquid and solid infections. 

1. Surgical gown classification

The four levels of protection available refer to surgical gowns, and it can be confusing to know which suits your needs best. FDA endorses the American National Standards Institute/Medical Device Development Association (ANSI/AAMI) PB70:2003 guidelines, which provide for testing and results to verify and confirm that the surgical gown provides a specific level of protection. To simplify our work, we have outlined four standardized levels of protection available according to the FDA guidelines, so you know exactly what level is necessary to keep your workplace safe for everyone.

So, what's the difference between the four levels of protection that disposable surgical gowns provide? Level 1 versus level 2? Level 2 and 3? Level 3 versus level 4?

Level 1 surgical gown

Level 1 surgical gowns provide the least protection and are usually used in general hospital settings or when medical and health workers provide only basic care without the need for sterile coveralls. These surgical gowns provide a slight barrier to fluid but are not suitable for drawing blood, intensive care units, or pathology laboratories.

Level 2 surgical gown

Surgical gowns with level 2 protection are ideal for low-risk situations, such as drawing blood from veins or working in pathology LABS and ICUs and do not require sterile suits. The level 2 surgical gown was tested by pressurizing the material used to make the dress and hitting it with water. These surgical gowns block more fluid than level 1 surgical gowns and are effective in preventing fluid penetration that may result from splashing or soaking.

Level 3 surgical gown

Level 3 surgical gowns are ideal for medium-risk situations such as arterial blood drawing, intravenous injection, emergency room, or trauma work requiring sterile coveralls and equipment. These surgical gowns are also effective against splashing and wetting. The same test for a level 2 surgical gown is used to test the effectiveness of a level 3 surgical gown.

Level 4 surgical gown

Level 4 surgical gowns provide the highest level of protection and can be used in all high-risk situations (for example, when performing an operation in an operating room that requires sterile equipment). These level 4 surgical gowns prevent fluids and viruses from penetrating for up to an hour. The surgical gowns were tested by exposing them to simulated blood containing the virus. If the virus does not penetrate the surgical gown at the end of the test, the dress can be designated level 4. These surgical gowns offer resistance to pathogens, protection against non-airborne diseases, and can prevent large amounts of fluid from entering the body. Extend the time.

2. How to choose the appropriate surgical gown to limit COVID-19 exposure

According to the CDC's COVID-19 resources, choosing the right level of surgical gown depends on the level of protection required for the situation. For patients with suspected or confirmed COVID-19, non-sterile, disposable surgical gowns are suitable for routine patient care in healthcare settings. For health care professionals engaged in activities with low or very low risk of fluid exposure, gowns requiring minimal or low levels of barrier protection (ANSI/AAMI PB70 Level 1 or 2) may be used. For a moderate to high risk of contamination and where a large critical area is required, a surgical gown (ANSI/AAMI PB70 Level 3 or 4) requiring moderate to high levels of protection can be used.

Please contact us for more information about the disposable surgical gown.