Like countless parents across the country, Austin resident and businessman Lloyd Armbrust has been trying to keep his five children safe and healthy during the coronavirus pandemic. When he couldn’t find child-size surgical masks, Armbrust created them himself.
Now, Armbrust’s objective is to secure Food and Drug Administration approval for the child-size masks, and has started a petition with that goal in mind.
“I want to protect my kids,” Armbrust said. He added that he’s been giving his kids’ adult-size surgical masks, but wants to provide them with a better-fitting alternative.
Armbrust’s Pflugerville-based company, Armbrust American, has been manufacturing surgical masks since May. It makes FDA-approved adult-size surgical masks and is close to receiving approval for its n95 masks.
Armbrust American is one of the few companies that sells masks directly to consumers, said Tom Cheredar, the company’s communications officer. Since its launch, the business has been a massive success, Armbrust and Cheredar said, the business has sold selling, to date, nearly 40 million masks. The company’s first few weeks of business saw so many orders that Armbrust spent much of that time in the shipping department, packaging and shipping masks himself.
As Armbrust American continued to take and fulfill orders, Armbrust said the first question customers asked was if and when the company would sell masks for children. That already had been on Armbrust’s mind since the beginning of the pandemic. Now, he thought, he had even more reason to create child-size surgical masks.
Armbrust and his team developed a smaller version of the company’s best-selling surgical mask. When it approached the FDA for approval, however, it learned the government body doesn’t approve child-size masks. The reason for this is relatively simple — surgical masks and n95 respirators are generally only used in work settings. Children don’t handle toxic chemicals or work in coal mines, so child-size masks that bear the government’s seal of approval don’t exist.
Masks receive FDA approval when they undergo testing showing they meet certain standards of bacterial and particulate filtration. Armbrust’s adult-size masks already meet those criteria, he said, and the child-size masks he wants to sell are the same product, just smaller in size.
While children don’t work in potentially dangerous settings, many are venturing into the world during a global pandemic. FDA approval showing that the mask is “safe and effective” would be beneficial for children’s safety and parents’ peace of mind, Armbrust said.
Further, some schools are using no-touch thermometers on students as a coronavirus safety measure, Armbrust said. Masks, unlike thermometers, would help students who are asymptomatic from potentially spreading the virus, he said.
“I think the FDA needs to reconsider,” Armbrust said. “There wasn’t a need before. But there is now a need.”
The FDA did not respond to requests for comment..
Armbrust’s company could sell child-size masks if it labels them as “non-medical.” However, Armbrust said he feels strongly that his product should receive FDA approval so he can ensure parents they’re getting the safest product — especially since the Centers for Disease Control and Prevention recently released guidelines recommending that children older than 2 should wear masks in public.
This is the main reason Armbrust decided to create a petition asking the FDA to give its approval to child-size surgical masks. The petition went live in late September and has just under 1,000 signatures, Cheredar said. Armbrust plans to leave the petition up at least through the end of the year.
“We want to use (the petition) to update the FDA,” Armbrust said. He’s hoping the FDA and other governmental bodies will see the petition, realize there is demand and consider changing its guidelines.
Armbrust American is ready to manufacture child-size masks as soon as the FDA approves them, Ambrust said. Until then, the company is continuing to make and sell its adult-size masks. It’s taking preorders for its n95 masks and will ship them when FDA approval is granted.
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