Clinical Level 3 AAMI Non-Sterile Impervious Isolation Gown Elastic Cuffs Universal Ultra Health Medical Online, Stores

Platinum Health Supply Groups Range of Disposable Isolation Gowns offers affordable and comfortable protection in all environments.

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 gown wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems. Gowns are one part of an overall infection-control strategy.

Product Size:

Universal Measurements (CM) –Garment Area Uni Size (S, M, L)
Length: 115cm
Sleeve Length: 57cm
Sleeve Width: 27cm
Neck Tie Length: 36cm
Sleeve Opening Relax: 8cm
Waist Tie Length: 170cm
Width: 135cm

Oversize Measurements (CM) –Garment Area Uni Size (XL, XXL, XXXL)
Length:125cm
Sleeve Length:60cm
Sleeve Width:29cm
Neck Tie Length:36cm
Sleeve Opening Relax:8cm
Waist Tie Length:180cm
Width:145cm

Medical Compliance:

TGA Listed product- This product is listed as a Medical Device Included Class 1

General Features:

• Universal Sizing (Small, Medium, Large)
• Elastic Cuffs
• Premium Polypropylene
• Ethical Sourcing
• Tie back & waist

General Information:

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.

Like surgical isolation gowns, non-surgical gowns should also cover as much of the body as is appropriate to the task. All areas of the non-surgical 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.

Areas of use:

Level 1 AAMI Risk Level (Minimal Risk) – During basic care, standard isolation, a cover gown for visitors or in a standard medical unit

Level 2 AAMI Risk Level (Low Risk) – During blood draws, suturing, in the intensive care unit (ICU) or a pathology lab

Level 3 AAMI Risk Level (Moderate Risk) – During arterial blood draws, inserting an intravenous (IV) line, in the emergency room (ER) or for trauma cases.

Level 4 AAMI Risk Level (High Risk) – During long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne).

Technical Information:

In the U.S., Level 1 and 2 isolation gowns are regulated by the FDA as Class I medical devices. Level 3 isolation gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.

International Standards:

American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapour transmission.

Below is a summary of ASTM F2407 standard recognized by the FDA.

• Tensile Strength: ASTM D5034, ASTM D1682
• Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM -D1424
• Seam Strength: ASTM D751 (stretch woven or knit)
• Lint Generation (ISO 9073 Part 10)
• Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Clinical Professionals via the contact us page.