A green revolution: FDA hands down emergency OK to plant-based surgical face mask
14 Oct 2022
Emergency Use Authorization
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Source: FierceBiotech
PADM Medical’s Precision Eco single-use face masks are constructed from plant-based materials that are manufactured from renewable crop resources, resulting in about 55% fewer carbon emissions than their plastic-based brethren.
“The unanticipated occurrence of a pandemic of this scale has resulted in unmanageable levels of biomedical plastic wastes,” the authors of an early 2021 study wrote, outlining the urgent need for the development of reusable or non-plastic alternatives to current personal protective equipment options.
Not a moment too soon, the FDA has bestowed an emergency use authorization upon a new medical-grade face mask that’s made of plant-based materials and can be composted.
The COVID-19 pandemic further exacerbated the already pressing issue of healthcare waste—which is estimated to total more than 5 million tons per year from hospitals alone. Alongside the sharp uptick in the use of single-use PPE and disposable test kits, so too did the amount of plastic-based waste sent to landfills reach new heights.
Case in point: The 2021 study estimated that 3.4 billion single-use face masks and shields were being discarded daily around the world.
The single-use mask comes from Canada-based PADM Medical, which shared the EUA news this week. Its Precision Eco masks are constructed from plant-based materials that are manufactured from renewable crop resources by Canada’s Roswell Textiles.
According to the mask’s maker, that biodegradable makeup enables the Precision Eco mask to generate 55% less carbon emissions than standard synthetic masks. Because of that net reduction, sales of the face coverings come with carbon credits to help offset buyers’ carbon footprints.
The plant-based offerings look just like the simple surgical masks that gained widespread popularity throughout the COVID pandemic, and have passed the same international standards for breathability, filtration, splash resistance and flammability.
Unlike their plastic-based brethren, however, the Precision Eco masks are industrially compostable, meaning they can’t be composted at home but will break down in a commercial compost center. Before sending them off to biodegrade, users must remove the elastic ear loops and aluminum nose wire from the masks.
Sustainability has seemingly been top of mind for the FDA in recent months. Earlier this year, it doled out a full 510(k) clearance—as opposed to the emergency nod given to PADM’s face coverings—for Showa Group’s biodegradable medical gloves.
The single-use gloves are powder-free and made out of nitrile butadiene latex, which doesn’t trigger allergies to natural rubber latex. In lab tests, the gloves took just over a year to break down by at least 80% in an active landfill and are expected to reach full decomposition between one and five years, much more quickly than the decades it takes regular nitrile gloves to break down.
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