PADM Medical receives U.S. Food and Drug Administration (FDA) 510(k) Clearance for PRECISION ECO™, the world's first plant

Jun 11, 2023

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13 Mar, 2023, 06:00 ET

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Bringing Sustainability to Healthcare: PADM Medical PRECISION ECO™ Plant based procedural mask with earloops receives 510(k) Clearance from the U.S. FDA – It is the world's first plant based procedural mask to receive a 510(k) for use in medical and healthcare settings

WINNIPEG, MB, March 13, 2023 /CNW/ - 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 today 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 United States of America.

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 world-wide 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 our 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," said Martin Petrak, PADM Medical Group CEO. "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 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," said 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 honoured 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?"

For more information about PADM Medical and PRECISION ECO™ visit: www.padmmedicalusa.com

PADM Medical Group (padmmedical.com) is a global leader in the design and development of medical devices, specifically eco-friendly sustainable medical consumables, and products. PADM Medical Group is a wholly owned subsidiary of the PADM Group.

Roswell Textiles is a global leader in biopolymer nonwoven technologies and materials, and the first and largest Canadian manufacturer of best-in-class synthetic and plant based meltblown nonwoven fabric (ECOFUSE™) for high performance, regulated medical, food grade, industrial filtration and consumer applications. Roswell Textiles' mission is to de-carbonize the nonwoven industry by developing plant based and low carbon materials on a large scale. Roswell Textiles is headquartered in Calgary, Alberta and is a wholly owned subsidiary of PADM Group.

The ECOFUSE™ platform technology is the world's first commercially available plant based meltblown nonwoven material that is rapidly helping transition the world towards a lower carbon and more circular material future. ECOFUSE™ materials are being used by Roswell Textile's strategic partners and clients to decrease the carbon footprint of their products. In addition to medical filtration, ECOFUSE™ materials are already commercial in water filtration and aerosol filtration applications with additional commercialization processes underway for the use of ECOFUSE™ materials in hygiene, food and beverage packaging as well as in construction materials. ECOFUSE™ meltblown materials, currently in commercial use in regulated medical applications, are certified to be 100% biobased by the United States Department of Agriculture BioPreferred Program.

PADM Group is an operationally diverse, advanced manufacturing conglomerate focused on mid to high volume manufacturing in the healthcare/medical, nonwoven textiles, energy/industrial and aerospace/defence industries. PADM Group has a brand focus on innovation and highly agile commercialization of sustainable technologies and products.

SOURCE PADM Medical

For further information: please contact Christopher Bélanger ([email protected]).