A note about Surgical Mask colors and FDA clearance
What’s the difference between our American Denim USA-Made Surgical Masks and Armbrust USA-Made Disposable Face Masks? That’s a very good question.
According to the FDA, only our American Denim (dark blue) 3-ply masks are considered medical-grade Surgical Masks. These masks are FDA cleared, which you can verify by reading our 510K documentation. American Denim are the only masks that can legally be called “Surgical” or “Medical-grade” masks on our packaging.
All other colors of 3-ply masks we sell (Black, Gray, Green, Pink, Red) are labeled and referred to as Armbrust “USA-Made Disposable Face Masks,” which you may have noticed. This is because the FDA requires a completely separate (lengthy and expensive) application process for every single variant color of a product a manufacturer produces. All of our color masks are made with exactly the same materials, with the exception of the dye color used in the outer layer of spunbond. Independent testing by Nelson Labs showed that the addition of colored dye to the masks in no way affected efficacy, according to lab results.
Here’s what hasn’t changed about all of our masks:
- Designed, developed, and manufactured at our Texas facility, each mask is rigorously tested for quality and safety.
- Constructed with virgin polypropylene
- Triple-layered, breathable, and lightweight
- Metal nose bridge for secure fit and less glasses fog
- Two-way protection
- Made in America