PADM Medical Group of Companies has secured a 510(k) clearance for the PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops from the US Food and Drug Administration (FDA).

The FDA clearance allows PADM Medical to market the plant-based procedural mask for use in medical and healthcare settings in the US.

PADM Medical Group CEO Martin Petrak said: “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.

“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.”

PADM Medical’s PRECISION ECO procedural masks are prepared using ECOFUSE plant-based materials. Its sister company Roswell Textiles, which is based in Calgary, Alberta, manufactures the ECOFUSE materials.

Manufactured from renewable crop resources, ECOFUSE materials are said to help bring down the adverse effect that petroleum-based, single use disposable face masks have on the environment.

According to PADM Medical, the ECOFUSE materials are compostable industrially and as they are plant-based, help cut down the CO2 emissions of PRECISION ECO by nearly 55% in comparison to traditional petroleum-based masks.

Besides, PRECISION ECO procedural masks produce carbon credits owing to the net carbon reduction, said the company.

Furthermore, the approved plant-based procedural mask is a US Department of Agriculture (USDA) Certified Biobased product under the USDA BioPreferred Program with the biobased content being 82%.

Roswell Textiles president and PADM Group chief innovation officer Kyle Fiolka said: “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…).”