Hospital gowns come in different levels, each with unique barrier protection qualities designed for specific environments. There is a testing process that all manufacturers must adhere to for their products to sell as medical-grade hospital gowns.
Each hospital gown level offers varying degrees of protection from fluids, making them uniquely suited for different medical field situations.
What Are The Hospital Gown Protection Levels?
The difference in protection levels between hospital gowns refers to their ability to provide a barrier against water penetration for the wearer. These gown levels are rated by the Association for the Advancement of Medical Instrumentation (AAMI). The AAMI levels of barrier protection have four tiers.
Level 1 Medical Gown – Minimal Risk
Level 1 hospital gowns are used for routine patient care where there is little to no risk of fluid exposure. The level 1 medical gown from ICU Productions is CPE, meaning it’s disposable.
These gowns are designed for a single use and are unsuitable for operating rooms. They can act as isolation gowns or be provided to hospital visitors as a way to protect their clothing. This is the lowest level of protection a gown can provide.
Level 2 Medical Gown – Low Risk
Level 2 gowns provide minimal to low fluid barrier protection. It’s worn for minimally invasive surgical procedures, where there is little risk of fluid exposure. Level 2 gowns can be worn when suturing, drawing blood, or working with patients in the ICU.
They are available in sterile and non-sterile and PE/PP or SMS variations.
Level 3 Medical Gown – Moderate Risk
Level 3 gowns offer medium/moderate protection from fluids and come in sterile or non-sterile material. These gowns are used for a wide range of surgical procedures and are suitable for the emergency room, performing an arterial blood draw, or treating trauma cases.
Level 4 Medical Gown – High Risk
Level 4 gowns provide the highest level of protection, offering a fluid and microbial barrier. Level 4 gowns protect against blood-borne pathogens in the critical zones and are suitable for lengthy, invasive procedures. These gowns do not offer protection from airborne pathogens. The FDA now requires that level 4 gowns pass an additional level of testing called ASTM F1671.
Testing Standards For Hospital Gowns
There is a rigorous testing process for all gowns sold in the United States as medical or hospital gowns. These are regulated by the FDA, based on guidelines set out by AAMI.
The standard for establishing levels 1-4 of protective apparel for health care is American National Standards Institute (ANSI) AAMI PB70:2012. Water resistance and liquid barrier penetration testing uphold this standard. Each gown type must pass its own testing requirements.
There is a single test of water hitting the gown to evaluate its liquid barrier performance at this level.
This level involves two tests that assess the barrier performance. One is pressurizing the material, and the other is applying water to the gown’s surface.
The same tests as level 2 are applied, but the gown must provide better protection against fluid penetration. The gown is also put under increasing pressure to see how it holds up.
Level 4 gowns undergo all the tests performed for levels 1-3, but they must also meet the high standard of ASTM F1671. This is a blood-borne pathogen protection test. The gowns undergo a barrier performance test being splattered with blood containing a simulated virus. To pass, there can be no trace of the virus penetrating the gown.
Critical Zones for Hospital Gowns
The different levels of protection that hospital gowns provide also come down to each gown’s critical zones. A critical zone is the parts of the gown that must provide the required level of protection. These are the regions that undergo the liquid barrier and pressurization testing. For most surgical gowns, the critical zones are located at the front because the back is not exposed to fluid during operating procedures.
Level 3 and 4 gowns feature critical zones at the sleeve, sleeve seam, front chest, and the front belt attachment point (if applicable).
Choose ICU Productions for Your PPE
For your PPE needs, choose ICU Productions. ICU Productions offers reliable, high-quality personal protective equipment, covering a wide range of protection types. From gloves to hospital gowns and face masks, you’ll find what you’re looking for.