What is an Isolation Gown?

Isolation gowns are examples of personal protective equipment used in health care settings. They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the isolation gown wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems. Medical Gowns are one part of an overall infection-control strategy.


A few of the many terms that have been used to refer to gowns intended for use in health care settings, include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns. (Source: “Medical Gowns | FDA”. 3/11/2020. fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns)

In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:


Level 1 Gowns: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

> 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.


Level 2 Gowns: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

> 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


Level 3 Gowns: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases


Level 4 Gowns: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

> 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.

(Source: “Medical Gowns | FDA”. 3/11/2020. fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns)

The are many names for an isolation gown and there is not standardize product names. Other common names include: barrier gowns, medical gowns, ppe gowns, reusable gowns, disposable gowns, non-surgical gowns

Choosing Which Isolation Gown to Use

When you are selecting PPE Gowns, consider three key things. First is the type of anticipated exposure. This is determined by the type of anticipated exposure, such as touch, splashes or sprays, or large volumes of blood or body fluids that might penetrate the clothing. PPE selection, in particular the combination of PPE, also is determined by the category of isolation precautions a patient is on. Second, and very much linked to the first, is the durability and appropriateness of the PPE for the task. This will affect, for example, whether a gown or apron is selected for PPE, or, if a isolation gown is selected, whether it needs to be fluid resistant, fluid proof, or neither. Third is fit. (Source: “Medical Gowns | FDA”. 3/11/2020. fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns : Please see: CDC Guidance for the Selection and use of PPE in Healthcare Settings: www.cdc.gov/HAI/pdfs/ppe/PPEslides6-29-04.pdf )

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