Level 1 Isolation Gown

Applicability: For use in minimal-risk situations. Basic care, standard isolation and medical units, visitors, simple biopsies, ear/nose/throat procedures and care. 

Material: Coated Polypropylene (PP+PE)

Performance Standards: Tested to Level 1 AAMI Standards. 

AATCC 42 ≤ 4.5 g

AATCC 127 N/A

Style: Neck Tie Closure, Elastic Cuffs, Sewn Seams, Belt Tie Waist 

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Level 2 Isolation Gown

Applicability: For use in low- risk situations. Blood draw, Suturing, ICU, Pathology Lab, Minimally invasive surgeries, Radiology/Catheter lab procedures

Material: Coated Polypropylene (PP+PE)

Performance Standards: Tested to Level 2 AAMI Standards. 

AATCC 42 ≤ 1.0 g

AATCC 127 ≥ 20cm water column 

Style: Neck Tie Closure, Knitted Cuffs, Taped Seams, Belt Tie Waist 

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Level 3 Isolation Gown (PP+PE)

Applicability: For use in moderate-risk situations. Arterial blood draw, Inserting an Intravenous (IV) Line, Trauma rooms etc. 

Material: Coated Polypropylene (PP+PE)

Performance Standards: Tested to Level 3 AAMI Standards. 

AATCC 42 ≤ 1.0 g

AATCC 127 ≥ 50cm water column

Style: Neck Tie Closure, Knitted Cuffs, Taped Seams, Side Belt Tie Waist  

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Level 3 Isolation Gown (SMS)

Applicability: For use in moderate-risk situations. Arterial blood draw, Inserting an Intravenous (IV) Line, Trauma Rooms etc. 

Material: Spunbond-Meltblown-Spunbond (SMS)

Performance Standards: Tested to Level 3 AAMI Standards. 

AATCC 42 ≤ 1.0 g

AATCC 127 ≥ 50cm water column

Style: Neck Tie Closure, Knitted Cuffs, Taped Seams, Side Belt Tie Waist  

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Materials

Spunbond Polypropylene (PP) :For basic infection control, this non-woven fabric bonds fibers together to form a single layer that is appropriate only for very minimal fluid exposure. 

 Coated Polypropylene (PP+PE): Soft, spunbond polypropylene coated with a layer of polyethylene (plastic) film to provide protection at an affordable cost, while allowing for breathability. 

 Spunbond/Meltblown/Spunbond Material (SMS): Composed of inner layers of meltblown polypropylene between outer layers of spunbond polypropylene. Ideal for extended wear, this strong and breathable material allows for protection and comfort. 

Performance Standards

What is an AAMI Standard? The association for the Advancement of Medical Instrumentation (AAMI) is considered the standard in surgical gown manufacturing. They test for standards such as barrier effectiveness against penetration from liquids, bodily fluids, blood and other infectious substances. All of Safe Direct’s gowns are AAMI rated and FDA approved

Testing

AATCC 42 (Water Resistance: Impact Penetration Test): This test measures the resistance of fabrics to the penetration of water by impact. The gown is stretched and mounted face up on an angled surface. A blotted paper is weighed and mounted behind the gown and water is then sprayed against the front of the gown. The blotted paper is reweighed to determine water penetration. If there is an increase in the mass of the blotted paper this means that water passed through the gown. The lower test results indicate that there is less penetration and better water repellency/resistance of the gown.

AATCC 127 (Water Resistance Hydrostatic Pressure Test): This test measures the resistance of the gowns to the penetration of water under hydrostatic pressure.  

Other Features 

Hot Lamination: We adhere a film of Polyethylene (PE) onto the Polypropylene (PP) base, to allow for fluid and vapour resistance while allowing for breathability.  

Seam Treatment: For our L2&L3 Isolation Gowns, we use taped seams. A strip of waterproof tape is used to cover the seams of the gowns and is then glued or heat bonded over the seam. This method allows for the best liquid resistance (in comparison to sewing or heat welding seams) and has the best results during our hydrostatic pressure tests. We use sewn seams for our Level 1 gowns, but it does not ensure as much protection as taped seams. 

Closure Styles: There are two options for closure styles on Safe Direct’s gowns. Neck tie on the back of the gown and over the head. Closure styles are not related to protection, but more so about user experience. Back tie options tend to be more comfortable for users in comparison to velcro closures.