Gowns

Surgical & Isolation Gowns

How to Determine Levels of Protections for Medical Gowns?

ANSI/AAMI PB70:2003 standard for liquid barrier performance:

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

AATCC 42 Water resistance - Impact penetration < 4.5g

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

AATCC 42 Water resistance - Impact penetration < 1.0g
AATCC 127 Hydrostatic pressure > 20cm

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

AATCC 42 Water resistance - Impact penetration < 1.0g
AATCC 127 Hydrostatic pressure > 50cm

Level 4: 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)

AATCC 42 Water resistance - Impact penetration < 1.0g
AATCC 127 Hydrostatic pressure > 50cm
ASTM 1671 Resistance by blood-borne Pathogen <1

Surgical Gowns

A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards.

Surgical Isolation Gowns

Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. As referenced in Figure 2, all areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.

Non-surgical Gowns

Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.

Isolation Gown 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

Application:

Blood draw from a vein, Suturing, Intensive care unit, Pathology lab

Isolation Gown Level 3

Isolation Gown Level 2

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

Application:

Arterial blood draw, Inserting an IV, Emergency Room, Trauma

Level 4

Isolation Gown Level 2

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.

Application:

Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid exposure over long periods

Personal protective equipmenT

Surgical & Isolation Gowns

How to Determine Levels of Protections for Medical Gowns?

Surgical Gowns

Surgical Isolation Gowns

Non-surgical Gowns

Isolation Gown Level 2

Isolation Gown Level 2

Isolation Gown Level 2

Isolation Gown Level 3

Isolation Gown Level 2

Isolation Gown Level 2

Level 4

Isolation Gown Level 2

Level 4

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