Spidertech Medical Mask Regulatory Approval
Spidertech is Canada’s largest manufacturer of kinesiology tape. In response to COVID-19, they wanted to produce a medical grade mask but needed external guidance on the regulatory process. They had a unique idea for a strapless mask made with their kin tape material for applications where straps around the face and neck are impractical, or a perfect seal of the mask is required.
The Health Canada approval process for masks was expedited early on in the pandemic, but in response to discovering 330,000 counterfeit N95 masks in 2021, Health Canada switched to their most stringent mask protocols in history. This switch happened during Spidertech’s initial Health Canada application. At this point, Spidertech had a design which was just the kin tape itself as the mask. In order to get their product to market quickly, I had them source a filter material from a list of Health Canada certified vendors (facilities that held an MDEL licence). Because they were then relying on an already approved filter material, their kin tape mask simply became the “holder” of the mask and not the mask itself in the eyes of Health Canada. After making this switch and resubmitting their application, their strapless face mask was then granted Health Canada licensing within a few days.
