Armbrust American

Explainer: Are masks FDA Approved? FDA Certified? FDA Listed?

Explainer: Are masks FDA Approved? FDA Certified? FDA Listed?

Armbrust American 3-Ply Disposable Protective Face Masks are FDA registered and listed, and have an ASTM Level 3 certification. Per the FDA website, face masks like ours are intended to be worn by the general public or healthcare personnel. They are medical grade, as they are suitable for use by healthcare personnel. But is FDA registered the same as FDA listed? Or FDA approved? Certified?

There are A LOT of misconceptions and misinformation about the type of certifications that the FDA issues, and it leads to a great deal of confusion. Additionally, there are plenty of face mask products making claims that make it even more confusing to determine if you’re getting a vetted, safe face mask because they mix “FDA” into marketing descriptions. Thus, this is a topic that requires more attention.

But first, let me explain the FDA’s medical device classification system. This can be a bit confusing...

There are class 1, 2, and 3 devices, and then there are devices that are categorized as Not-Classified. ALL of these things fall under the oversight of the FDA. Classification is determined not only by what risk the device poses to the patient or user, but also the intended use and indications of the device.

Strictly speaking, the only products that the FDA APPROVES, are drugs and serious medical devices -- think of things like your prescription medication or a pacemaker. So in terms of medical devices, generally “Class 3” devices are the things that you would get FDA approval for.

“Class 2” devices, which include things like N95 respirators, surgical and procedure masks, powered wheelchairs, or pregnancy tests, don’t typically get FDA approval. Instead, they are often considered FDA CLEARED. Around 43% of medical devices fall under this category.

And then there are “Class 1” and “Not Classified” devices. These things are all pretty similar. Think of things like tongue depressors, elastic bandages, and, in our case, protective face masks. These are items that present minimal potential for harm to users, and are often simple in design. Most devices fall into these categories. The vast majority of these devices are FDA listed and registered.

FDA Registered Surgical Masks

What Classification Are Armbrust Surgical Masks?

Unlike the majority of disposable protective face masks sold directly to consumers, our masks fall within the Class 2 group of devices, having passed intense testing and evaluation from Nelson Labs. That means we’ve earned the right to call our masks Surgical Masks, as they are intended for general use by the public as well as healthcare professionals.

Armbrust American face masks are made from the best materials available, including the highest quality non-woven polypropylene fabric, as well as meltblown polypropylene filtration material.

Making sure that only good quality products get into the hands of Americans is important. Unlike so many other manufacturers on the market right now, we’ve put our products through all of this testing and scrutiny so that you feel the ultimate confidence in wearing Armbrust American masks.

You can find our manufacture and product listing on the FDA website under Armbrust Inc., and our FDA registration number on our website. We are happy to provide additional information regarding our registration if necessary.