Level 1 vs Level 2 Isolation Gowns: What’s the Difference?

Level 1 vs Level 2 Isolation Gowns: What’s the Difference?

The pandemic has highlighted the need for quality PPE in and out of health care settings. Surgical gowns are used to protect the wearer and prevent them from spreading harmful microorganisms, such as bacteria and viruses to other patients they come into contact with.

Surgical gowns can be labeled in a number of different ways, including cover gown and procedure gown, as well as isolation gown, which is the term we will use for the purpose of this article. While the names can be used interchangeably, the most important thing is to identify the level and ensure you have the right one for the work you or your staff are doing.

What’s the Difference Between a Surgical Gown and Isolation Gown?

While the level designation is the same, the difference lies in the design of the gown. Surgical gowns have a “critical zone” which is from torso to knee, and from just above the elbow to the wrist.

An isolation gown is a critical zone in it’s entirety, everything besides the hems and cuffs must have a high level of liquid barrier protection in relation to it’s level. This includes seams, and it must cover as much as the body as is necessary for its intended use.

Isolation gowns are, by nature, intended for more high-risk applications. For example, if there is a medium to high risk of contamination. Of course, this is particularly important today, and so isolation gowns are used often.

What’s a Level 1 Isolation Gown?

A level 1 isolation gown is the lowest level of protection, considered “minimal risk”. A level 1 isolation gown is designed to be used for basic care, such as by those working in hospice, care homes, or low-risk wards. It is also the level given to visitors, for example, after someone has given birth. It provides a “slight” barrier to small amounts of fluid penetration.

What’s a Level 2 Isolation Gown?

A level 2 isolation gown is the next step up, and is considered “low risk”. This is the gown that needs to be used for working in the ICU or other more intensive care situations outside of the hospital. It’s also necessary when doing stitches and sutures, drawing blood, or working in laboratory settings with pathogens. Level 2 provides a barrier to “large” amounts of fluid, and even some soaking.

What’s the Difference Between Level 1 and Level 2 Isolation Gowns?

As you can see, the difference is significant in the amount of protection they offer, and in which situations they are suitable for use. Level 1 is suitable for any low-risk or routine care situation where it is highly unlikely there will be blood or other bodily fluids. It is simply necessary to take precautions to protect the wearer and anyone in their care from the spread of microorganisms.

Level 2 is necessary when there’s a high likelihood that the wearer may come into contact with blood, bodily fluids or infectious microorganisms, such as when suturing, drawing blood, working in the ICU, or in pathology. Level 2 offers significantly more protection than Level 1.

There are two further levels, Level 3 and Level 4. These are for use in circumstances where you are likely to come into contact with bodily fluids, such as trauma cases, fluid-intense surgical procedures, and when non-airborne infectious diseases may be present, and so are reserved for moderate and high-risk situations.

Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.

Type of PPEFeature TestedStandard DesignationSub headingsDescriptionApplicability
GownsLiquid Barrier PerformanceAAMI PB70:2012Classifies a gown’s ability to act as a barrier to penetration by liquids or liquid-borne pathogens based on four levels.
The critical protective zones for surgical and non-surgical gowns are defined differently by the standard.
While the critical zones designate different protective areas for the different gowns, the levels of protection are the same for both surgical and non-surgical gowns
Liquid barrier performance is not related to the strength of the material.This standard references several other standards
Level 1
  • Used for MINIMAL risk situations
  • Provides a slight barrier to small amounts of fluid penetration
  • Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
basic care, standard hospital medical unit
Level 2
  • Used in LOW risk situations
  • Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking
  • Two tests are conducted to assess barrier protection performance:
    • Water impacting the surface of the gown material
    • Pressurizing the material
Blood draw from a vein, Suturing, Intensive care unit, Pathology lab
Level 3
  • Used in MODERATE risk situations
  • Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
  • Two tests are conducted to test barrier protection performance:
    • Water impacting the surface of the gown material
    • Pressurizing the material
Arterial blood draw, Inserting an  IV, Emergency Room, Trauma
Level 4
  • Used in HIGH risk situations
  • Prevents all fluid penetration for up to 1 hour
  • May prevent VIRUS penetration for up to 1 hour
  • In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.
Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid exposure over long periods

Source: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns