PADM Medical Group of Companies (PADM Medical Canada and PADM Medical USA), a global leader in the design and development of sustainable medical consumables and eco-friendly sustainable medical products, announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market 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.

Billions of petroleum based synthetic disposable surgical masks are discarded globally on an annual basis. Increasingly, governments and consumers are recognizing the environmental threats posed worldwide by this plastic pollution. Most disposable personal protective equipment (PPE) consists of petroleum-based, non-biodegradable polymers that can take up to 450 years to decompose in landfills, rivers, lakes and other natural environments.

PADM Medical’s PRECISION ECO Plant Based procedural masks are made using ECOFUSE plant-based materials manufactured by PADM Medical’s sister company, Roswell Textiles, in Calgary, Alberta. ECOFUSE materials are manufactured from renewable crop resources and help reduce the adverse impact on the environment of petroleum based, single use disposable face masks. The ECOFUSE materials are industrially compostable and by being plant-based, help reduce the CO2 emissions of PRECISION ECO by approximately 55% compared to conventional petroleum-based masks. PRECISION ECO procedural masks also generate carbon credits as a result of the net carbon reduction.

Additionally, the PRECISION ECO Compostable/Plant Based Procedural Mask with Earloops 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,” says Martin Petrak, PADM Medical Group CEO. “For the first time ever, the U.S. 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 tonnes 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,” says 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?”