Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.) in Brampton, Ontario, has been selling personal protective equipment (PPE), including gowns, masks and gloves, via social media and websites such as Kijiji without the required Medical Device Establishment Licence (MDEL) from Health Canada. Canadians are advised to immediately stop using these products and to dispose of them as they may not provide the level of protection advertised due to unknown quality and safety. This company does not hold a MDEL, which is required to import or sell medical devices (including PPE) in Canada. Health Canada also refused an application from the company for authorization to sell its gowns under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 because they did not meet all of the requirements. Despite Health Canada’s direction to stop sale, the company continued to sell its isolation gowns to various health care practitioners and consumers. Maskopia has also falsely advertised and sold non-medical masks as medical masks. Health Canada has seized the following products from the company: N95 masks K95 masks Isolation gowns Face shields CPR face shields Cloth masks advertised as surgical masks Disposable surgical masks Latex and vinyl gloves For more information about medical gowns, PPE and the Health Canada authorization process, please visit: COVID-19 personal protective equipment (PPE) .
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