FDA OKs First Plant-Based, Medical-Grade Face Mask

PADM Medical Group of Companies, a designer and developer of sustainable medical consumables and eco-friendly medical products, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its PRECISION ECO compostable/plant based procedural mask with earloops, the world’s first plant based, procedural mask for use in healthcare and medical settings in the U.S., according to the company.
 
Most disposable personal protective equipment (PPE) is made of petroleum based, non-biodegradable polymers that can take up to 450 years to decompose in landfills, rivers, lakes, and other natural environments.
 
PRECISION ECO masks are made from ECOFUSE plant-based materials manufactured by PADM Medical’s sister company, Roswell Textiles. The materials are made from renewable crop resources and are industrially compostable. By being plant-based, the PRECISION ECO masks help reduce CO₂ emissions by about 55% compared to conventional petroleum-based masks. The PRECISION ECO masks also general carbon credits due to the net carbon reduction.
 
Further, the mask is a USDA Certified Biobased product under the USDA BioPreferred Program with a biobased content of 82%.
 
“The 510(k) Clearance on the 82% plant-based PRECISION ECO product is a tremendous milestone, not only for PADM Medical, but also for the healthcare industry and our planet,” Martin Petrak, PADM Medical Group CEO told the press. “For the first time ever, the US healthcare system now has a plant based medical grade face mask alternative that provides the same level of protection as a traditional synthetic plastic product. Our PRECISION ECO mask achieves a net 55% reduction in carbon emissions and minimizes the larger environmental damage caused from the millions of tons of synthetic plastic medical waste that is generated on an annual basis by traditional face masks. It is this commitment to our planet that drives us as a company as we continue to innovate for a greener and more sustainable world.”
 
“The FDA 510(k) clearance is the highest level of validation available for the use of ECOFUSE materials in one of the strictest regulatory environments possible—healthcare,” added Kyle Fiolka, president of Roswell Textiles and chief innovation officer for the PADM Group. “Roswell Textiles’ ECOFUSE materials are allowing manufacturers to reduce the carbon footprint of their existing product lines, without sacrificing performance or technical standards. We are honored to have worked alongside PADM Medical as they pursued this momentous achievement. This opens the doors to ECOFUSE materials becoming the new standard plant based material for healthcare single use disposables (gowns, drapes, sheets, wraps, the list goes on…). If a hospital could reduce their carbon emissions by up to 55% per product line as a result of a more sustainable supply chain decision, why wouldn’t they do that?”