Canadian 95PFE certification, equivalent to N95 for respiratory masks

Montreal, September 3, 2020 – Shapeshift 3D, a software company based in Montreal, is pleased to report the launch of Health Canada’s 95PFE, a Canadian-based certification for respirators equivalent to the U.S.-based N95. These masks, used in health and industrial environments to protect workers from airborne particulates, will now be tested and certified in Canada. This will eliminate the dependency of suppliers and customers on U.S. certification services.

Demand for N95 masks has exploded since the beginning of the COVID-19 pandemic and has caused significant supply issues. Many companies, including Shapeshift 3D, have quickly committed themselves to fill that gap, increasing the load on the certification service department of the National Institute for Occupational Safety and Health (NIOSH) on which Canada has been relying for several years. Following NIOSH’s decision to suspend new applications for N95 masks from suppliers located outside of the United States, Health Canada, the Public Health Agency of Canada (PHAC) and the National Research Council of Canada (NRC) will work together to support Canadian manufacturers wishing to propose an alternative to N95-certified respirators, while adhering to the same testing and quality requirements.

This is great news for Shapeshift 3D whose Beyond-Fit™ mask, perfectly adjusted to each individual, could be among the first to achieve 95PFE certification. This approval will open the doors to widespread deployments in hospitals and in industries where workers are exposed to hazardous dust.

Aurelia, partner of Shapeshift 3D for the manufacture and distribution of the Beyond-Fit™ masks, will soon perform pre-tests with the CTT Group in Saint-Hyacinthe (Quebec) (https://gcttg.com/en/). Once these pre-tests have been successfully completed, the masks will be sent to the NRC for final certification.

“We are thrilled by Health Canada’s announcement regarding the Canadian 95PFE certification for respirators. In addition to our Health Canada manufacturing license, we have already completed all ASTM standard tests on filter material with Nelson Labs. These results confirmed our filters will provide protection and overall performance levels adequate for use during surgical procedures. The upcoming R5 testing of the Beyond-Fit™ Mask is the final step in the complete certification for all Canadian markets.” explains Aurelia’s Director of Innovation and Marketing, Gabriel Coulet.

“We cheer this major development, which will only benefit the health and well-being of Canadian workers,” added Jonathan Borduas, CEO and founder of Shapeshift 3D.

About Shapeshift 3D

Shapeshift 3D (https://www.shapeshift3d.com) develops software solutions to automate the customization of medical, sports and protective equipment by using the 3D scan of an individual for the 3D printing of a perfectly adapted product. Shapeshift 3D is the designer of the Beyond-Fit™ mask (https://www.shapeshift3d.com/beyond-fit-mask), a comfortable and safe personal protective equipment.

About Aurelia

Aurelia Gloves Canada® is a division of Group Supermax, a company located in Berhad, Malaysia. The Supermax group is the second largest manufacturer of disposable gloves in the world and exports its products to more than 160 countries. Founded in 2004, Aurelia Gloves Canada® is located in Longueuil and is home to 20 employees. As a manufacturer of its own products, Group Supermax has developed a range of successful brands such as Supermax, Aurelia and Maxter, which offer products such as gloves, masks and other reliable personal protection equipment recognized by laboratories, hospitals, pharmacists, doctors and surgeons around the world.

About the Canadian 95PFE certification

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/medical-masks-respirators/safety-performance-specifications.html

Source:

Shapeshift 3D

info@shapeshift3d.com

+1 866-258-8593

Shapeshift 3D

6415 Des Écores #2

Montreal Quebec, H2G 2J6

Canada

+1 866-258-8593

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