Best Surgical Masks Authorized by the FDA

Aug 24, 2023

Picking the best surgical mask to stay safe is still a challenge, but you can choose from the best surgical masks that are FDA cleared with a little guidance. Rather than focusing on 3-ply disposable masks, this roundup looks at surgical N95 masks that are most often used in medical settings.

These surgical masks range from $2.36 to $3.49 each and are available from several online retailers and manufacturers.

Here are the best surgical masks that you can buy online that are FDA cleared and National Institute for Occupational Safety and Health (NIOSH) approved. Prices are per mask, and minimum-order quantities apply. These surgical masks are not reusable.

While these masks are most often used in a medical setting, some people are using them as personal protection from COVID-19.

Read on for more information about each option and learn about the differences between a surgical mask and a surgical N95 mask.

You can buy two types of surgical masks. The more common 3-ply disposable face masks are often referred to as surgical masks.

Surgical N95 masks are specifically regulated by the FDA and approved through NIOSH. This combines a level of vetting across the two organizations.

A standard surgical mask can cost as little as 29 cents each and does not typically form a tight seal to your face. It's a mask that falls under the double mask recommendations.

The CDC defines a surgical N95 respirator as "a NIOSH-approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask." A surgical N95 mask has fluid resistance and is designed to withstand a spray of fluid.

A surgical N95 mask is characterized by around-the-head straps, a tight fit to the face and an adjustable nosepiece.

Each surgical N95 mask includes FDA clearance and a NIOSH approval number. If you're in doubt about a mask, you can contact the FDA for clearance information at 800-638-2041.

Both types of surgical masks are available in various sizes, so it's important to make sure you choose the correct size.

The RespoKare N95 surgical mask is an FDA-cleared anti-viral face mask. This is a four-layer mask with an inner anti-viral layer that contains copper and zinc ions. This mask is FDA cleared (K122702) and NIOSH approved (84A-7796). You can purchase it in quantities as low as two masks. These are available in small, medium and large sizes.

Buy at Well Before.

The Dasheng DTC3B N95 surgical mask is an affordable option that meets all the surgical mask requirements. This mask is FDA cleared (K090131) and NIOSH approved (84A-4336). It's made using ultrasonic welding technology for a glue-free and odorless design.

Buy at Well Before.

The Aero Pro AP0028 N95 is a duckbill-style surgical mask with high ratings on Well Before. The FDA clearance is K072067, and the NIOSH approval is 84A-4175. This mask is available in quantities as few as two masks.

Buy at Well Before.

The Makrite 910-N95FMX Surgical Particulate Respirator is designed for protection from solids, but it's also FDA cleared (K020474) and NIOSH approved (84A-4541). Makrite states that this mask is extremely durable and features a soft inner lining.

Buy at Well Before.

The Makrite 9500-N95 respirator surgical masks are available in regular and small sizes. This is important, as smaller sizes are tougher to find right now. These masks are FDA cleared (K020474) and NIOSH approved (84A-5411). They are latex free, which is not a claim we see on many masks.

Buy at Well Before.

The Aero Pro AP0018 N95 surgical mask is a cup-style mask that offers protection from particulates and fluids. The mask is FDA cleared (K072067) and NIOSH approved (84A-4049).

Buy at Well Before.

The Halyard Fluidshield N95 mask is a duckbill-style surgical mask that's made in the Americas. These masks are FDA cleared (K143287) and NIOSH approved (84A-7521). Amazon offers these in a pack of 35 masks.

Buy at Amazon.

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