Health experts are recommending that the U.S. public upgrade from cloth masks to surgical masks or N95 respirators due to the surge of the highly contagious COVID-19 variant, Omicron.

Cloth masks have been generally preferred due to comfort and aesthetics, but experts believe cloth masks do not provide adequate protection from Omicron. As the advice to upgrade prevails, demand for N95 respirators and surgical masks has been increasing.

Keep reading to learn about marketing these products in the United States.

Why are Experts Recommending an Upgrade from Cloth Masks?

Though cloth masks, surgical masks, and N95 respirators are used to protect against
COVID-19, the level of protection varies by type:

• Cloth masks can offer some protection from COVID-19 by blocking large particles that may contain the virus but are not as effective at blocking small particles.
• Surgical masks are made from a plastic material called polypropylene, which can hold an electric charge that attracts and removes foreign particles from the mask. Surgical masks are tested for particulate and bacterial filtration efficiencies and biocompatibility.
• N95 respirators offer a snug fit to the face and filter 95 percent of airborne particles, making them a popular choice for healthcare settings.

In December 2021, the Mayo Clinic announced that it is requiring all patients and visitors to wear a surgical mask or N-95 respirator rather than a cloth mask. According to the mandate, anyone wearing a single-layer cloth mask will be provided a surgical/procedural mask to wear while on the premises. Medical and viral experts are echoing Mayo Clinic’s concerns and showing increased support for upgraded masking efforts.

Manufacturers of surgical masks and N-95 respirators can help fulfill the increased demand by properly preparing their products for the U.S. market.

Requirements for Marketing Surgical Masks and N-95 Respirators

To submit your surgical mask for Emergency Use Authorization (EUA), your mask must meet FDA’s criteria for liquid barrier production. FDA requires test reports that demonstrate the surgical mask’s efficacy.

For FDA to authorize your N-95 respirator under an EUA, your product must first be approved by the National Institute for Occupational Safety and Health (NIOSH). Once your respirator receives NIOSH approval, it is authorized under the EUA for NIOSH-approved air-purifying respirators.

As opposed to pursuing an EUA, you can also submit an application to FDA through a traditional regulatory pathway, such as 510(k) or PMA, so that you can continue marketing your product after the public health emergency ceases.