Our gowns maintain their integrity even after 3 wash cycles and pass the required level 3 barrier test for the FDA’s Emergency Use Authorization allowing for cost savings as compared to single-use disposable gowns.
Our gowns meet these Standards for Level 3 Protective Gowns: Passes AATCC 42 Water Resistance Test on as Received and after 3x Laundering Cycles | Passes AATCC 127 Hydrostatic Pressure Test on as Received and after 3x Laundering Cycles | Meet Requirements for Flammability as defined by 16 CFR 1610.
This gown is compliant with the FDA’s Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency, dated March 2020. It has specifically met test standards at an accredited laboratory to ensure the product’s high performance against specific level 3 tests.
These products are only recommended for use when standard apparel is unavailable, and only during the duration of the COVID-19 Public Health Emergency / the duration of the FDA’s Enforcement Policy.
The Protective has not been tested against the full range of tests required by ASTM F2407-06(13)e1, has not been subject to a pre-market filing, and makes no claims regarding Tear strength; Seam strength; Breathability; Lint generation; Infection reduction or prevention; Effectiveness against a particular disease, including SARS-CoV-2 / COVID-19.
Test Data Sheet available upon request.