Right now, we do not offer a smaller size for our surgical masks. Currently, the FDA will not approve of a child-size surgical mask. Armbrust American has launched a petition urging the federal government to change this policy. You can sign the petition and get updates about when they will be available HERE.
ASTM Certification is given to products like face masks to determine the level of filtration effectiveness. Masks undergo extensive testing by a trusted third-party laboratory, and assigned one of three ratings:
Level 1 - Unable to filter out microscopic particulate matter (such as viruses), NOT rated for medical use. Level 1 masks are unregulated by agencies like the FDA.
Level 2 - Able to filter out particulate matter of microscopic viruses such as the novel coronavirus. Level 2 masks must be FDA listed to gain approval for medical use. Product CANNOT be called “surgical” without it.
Level 3 - Meets all the requirements necessary for Level 2 certification. Additionally, Level 3 rated masks must pass synthetic blood and fluid penetration testing. Level 3 rated masks must also be FDA-listed for medical use.
(NOTE: Armbrust American Surgical Masks have an ASTM Level 3 certification and are FDA-listed for approved medical use. Learn more HERE)
Armbrust American's Surgical Masks recently gained ASTM Level 3 certification, the highest possible quality and safety rating. This applies to all masks we sell -- however, updated product packaging may be delayed for a month or more.
Yes, Armbrust American Surgical Masks are FDA Listed, meaning they have passed extensive and rigorous testing and are officially approved for medical use.
An FDA-Listed surgical mask differs from masks included in the FDA's Emergency Use Authorization (EUA) list, which the government agency developed in response to a shortage of PPE at the beginning of the coronavirus pandemic. EUA face masks only have temporary authorization, but are not verified for quality and safety.
You can read more about FDA's approval processes HERE.
Armbrust surgical masks have five parts: the elastic ear loops, nose wire, and three layers of non-woven fabric made from polypropylene plastic. The middle layer, called meltblown, has an electrostatic charge that makes it very effective at filtering out particulate matter as small as 0.1 microns.
Learn more about what and how Armbrust American Surgical Masks are made of HERE.
Armbrust American has developed a N95 Respirator mask, which is currently awaiting review from the FDA. Unfortunately, this is a long process that takes time. Customers who have pre-ordered N95 masks will be notified with updates as we learn more, and can email our support team to make adjustments to their order.
Additionally, you can subscribe here for updates when N95 masks become available.