24. Oct 2022
PADM Medical (Winnipeg, MB, Canada) PRECISION ECO™ plant-based procedural mask with ear loops receives emergency use authorization (EUA) from the US FDA – It is the world's first plant based procedural mask to receive EUA for use in medical and healthcare settings.
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, recently announced that it has received its Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA)  to market Precision Eco, the world's first plant-based, procedural mask with ear loops 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, made using ECOFUSE™ plant-based materials manufactured by Roswell Textiles from renewable crop resources, will 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 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 EUA on the Precision Eco product is a milestone. It is a reward to our commitment to making eco-conscious products to support the health and wellness of all individuals and our planet. This commitment drives us as a company as we continue to innovate for a greener and more sustainable world. We are working in collaboration with our global partners to develop the vast potential of our Precision Eco plant based/compostable masks", said Martin Petrak, PADM Medical Group CEO.
Derek Atkinson, VP of Business Development at TotalEnergies Corbion added, “We should not accept the limitations of the current way of doing things as being the only way. As we try to minimize the impact of our products on the environment, it is these developments that help us realize these ambitions”. He continued, “as the supplier to PADM Medical Group of the high purity polylactic acid (Luminy® PLA) needed in the production of these ground-breaking biobased surgical masks, we are delighted to learn that PADM has succeeded in obtaining Emergency Use Authorization from the US FDA”. AT
 The product has not been FDA cleared or approved.
 The product has been authorized by FDA under an EUA for use in healthcare settings by Health Care Practitioners (HCP) as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
 This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.