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

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...

How the FDA device classification system works

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.

FDA Class 3 

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.

FDA Class 2 

“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.

FDA Class 1 or Not Classified

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.

FDA Registered Surgical Masks

What FDA Classification Are Armbrust Surgical Masks?

Armbrust American is an FDA Registered manufacturer. Our 3-Ply Disposable Protective Face Masks are FDA-listed, and have an ASTM Level 3 certification.

Unlike the majority of disposable protective face masks sold directly to consumers, our masks have  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.

Which surgical masks are FDA approved?

Technically, masks are not approved. They are type two medical devices. They’re “cleared.” Only a type three medical devices is going to be “approved.” Getting “approved” is like a super deep process the FDA goes through. So if you’re going to have a fake heart or something, that’s going to be FDA approved. But an FDA mask is typically “cleared.”

This means they look at third party tests, good manufacturing processes, they’re checking to make sure you’re doing the right thing. And the reason for that is, if you put “surgical” on a box, the FDA will come after you pretty quickly.

No box is going to say “surgical” unless its gone through an FDA process.

What if a box says “medical-grade mask”?

It’s bull****. You would not see a mask that says “medical grade mask” in the United States. If you did, it’s an utter fabrication that somebody made up. In the United States, “medical grade” is not a thing. That would be a pure marketing term.

We actually say “medical grade” masks because people ask for them. But if you look at what’s on our label, it’s “surgical mask.”

What surgical masks are made in the USA?

So, I’m going to teach you how you can answer this question for yourself. Because it’s amazing that people don’t know to do this.

  1. Go to the FDA’s website.
  2. In the Product Code, enter FXX.
  3. In Establishment Type, enter Manufacturer.
  4. In Country, enter United States.

You’ll find many different companies including contract manufacturers, importers, foreign private label, etc. But what you care about is manufacturer, that’s going right to the source.