The Difference in Hospital Gown Protection Levels

A hospital protective gown is a critical piece of personal protective equipment (PPE), available in different varieties to offer a barrier against illnesses, infectious diseases, or bodily fluids. Medical gowns can also prevent health care workers from transferring harmful microorganisms from patient to patient.

There are four levels of hospital protective gowns that are rated according to the Association for the Advancement of Medical Instrumentation (AAMI) level standards.

Different Levels of Hospital Gown Protection

The four levels of medical grade gowns are tested according to AAMI, a consensus standard that has been recognized by the FDA since 2004. To adhere to these standards, hospital gowns undergo testing to ensure their performance results meet the required level of protection.

Hospital gowns are also commonly referred to as surgical gowns, medical gowns, and isolation gowns. Gown levels 1-4 are all uniquely suited to different medical environments where patient care is provided:

Level 1 – Minimal Risk

Level 1 medical gowns offer the lowest level of protection. Level 1 gowns act as a limited temporary barrier for hospital visitors, excision biopsies, basic ENT (ear, nose, throat) procedures, or standard isolation, offering protection from small amounts of fluid.

Level 1 gowns should only be used in situations with minimal risk of exposure to harmful substances or bacteria.

Level 2 – Low Risk

Level 2 gowns are for situations where there is a low risk of exposure. This can include medical staff working in the ICU, drawing blood, or performing an MIS (minimally invasive surgery). This gown level provides better fluid protection for splatter and soaking. These come in sterile and non-sterile varieties and can be PP/PE or SMS material.

Level 3 – Moderate Risk

Level 3 gowns are rated for moderate risk environments such as the emergency room, inserting an IV, arterial blood draws, or handling a trauma case. They can protect from larger amounts of fluid through splatter and soaking. Level 3 gowns can be made of sterile or non-sterile material.

Level 4 – High Risk

Level 4 medical gowns offer the highest level of protection against water penetration. These gowns are suitable for lengthy surgical procedures and the operating room, where the risk of contact with fluid is high (like a cesarean section). Level 4 gowns also offer protection against non-airborne infectious pathogens.

ICU Productions also stocks level 4 coveralls which offer a better high-level barrier from fluids, but also allow uninhibited movement without impacting the protection level. For situations where your head and shoes benefit from coverage, these are an effective PPE option.

Hospital Gown

What Is a Non-Surgical Gown?

A non-surgical gown is a disposable protective barrier that is exempt from review of AAMI and FDA standards. While surgical gowns are FDA Class II medical devices requiring pre-market review, non-surgical gowns are regulated as Class I.

Surgical and non-surgical gowns also have different critical zones, which are the areas that must feature the highest level of protection.

Hospitals evaluate which gowns they should purchase for their staff based on a few simple criteria:

  • Type of procedure
  • Duration of the procedure
  • Amount of potential fluid exposure

Based on these areas, clinicians can select the correct gown level to keep them adequately protected.

How Are Medical Grade Gowns Tested?

The AAMI introduced ANSI/AAMI PB70:2012 as the standard for testing medical gowns in the United States. These standards help identify the key areas requiring protection from fluid exposure for each grade of gown.

Level 1 to level 4 hospital gowns undergo liquid barrier performance testing at varying intensities. Liquid barrier performance is not directly related to the strength of the gown, but rather its water resistance.

Level 1 medical gowns have barrier protection assessed based on a single impact penetration test of water against the gown’s surface.

Level 2 gowns are intended for situations where a risk might be present, and must prevent soaking in addition to splatter from penetrating the gown. That’s why testing is ramped up for level 2. These gowns must be assessed for water impact, plus withstand pressurization to see if the gown can handle the increasing pressure without tearing. Level 3 gowns are tested in the same way.

Level 4 medical gowns pass more intense testing measures. They must be able to handle constant contact with liquid for up to one hour and still prevent penetration. Since this medical gown grade must protect against blood-borne pathogens for one hour, there is also a virus test with simulated blood.

The gown will pass testing if no trace of the simulated virus is found to have gotten through the gown to the clothing underneath.

Understanding the Critical Zones

For a surgical gown to be classified as level 4, it must pass the ASTM F1671 in its critical zones, according to AAMI standards. The critical zones are the areas of the hospital gown most likely to come in contact with fluid, either by splatter or soaking.

For a level 4 surgical gown to be approved, the critical zones that must pass testing include the front chest, sleeve seam, sleeve, and front belt attachment.

Surgical isolation gowns and non-surgical gowns have larger critical zones because they are used in an environment where the risk of contamination in other areas of the gown is possible. These gowns often have critical zones at the back and sides as well, unlike a surgical gown.

Shop Medical Gowns From ICU Productions

Hospital gowns are essential to protecting health care workers from fluid exposure, harmful microorganisms and blood-borne pathogens. Choosing the right gown for your risk level ensures you’ll be protected where it counts.

ICU Productions carries level 1 CPE gowns and level 2-3 medical gowns, along with level 4 coveralls. Shop all your PPE needs from a reliable brand with a wide range of gear for you and your team.