We’ve Secured 510(K) Clearance for our Full Back Gown. Here’s What That Means for American Made PPE.

Since we launched Wildcat PPE in April, we’ve experienced so many milestones. Like other U.S. manufacturers that stepped up to manufacture PPE domestically, we were driven to help our nation’s medical workers. And to meet that demand quickly, we began operating under the FDA’s Emergency Use Authorization (EUA). We’ve since set up a new facility in Conroe to boost our manufacturing output. We’ve also expanded our line of Made in Texas PPE. And today, we reached our most important milestone yet: being the first domestic manufacturer to secure 510(K) clearance for a full back isolation gown.

Here’s how our 510(K) clearance will help America’s medical workers—and ensure that the shift to American made PPE is here to stay.

The Ongoing Need for Made in America PPE

Flashback to December 2019. The first case of the novel coronavirus had just been detected in Wuhan, China, but it hadn’t yet hit the world’s radar. By mid-January, that was quickly beginning to change. The first case outside of China was confirmed in Thailand on January 13. Although COVID-19 hadn’t yet begun to wreak havoc on Europe and North America, one thing was already beginning to worry foreign governments: the long-standing reliance on Chinese manufacturing.

At the start of the pandemic, a staggering 90% of the world’s medical PPE was manufactured in Wuhan. The majority of U.S. PPE came from China. When exports began to shrink as COVID-19 unfolded, this left an enormous vacuum—and a dangerous level of unmet need. To get medical professionals the protective gear they needed, companies like Wildcat PPE stepped up. The FDA also stepped up, providing an EUA to help manufacturers quickly meet unprecedented demand.

As we enter the second year of the pandemic, those early PPE shortages have eased. But demand for N95s is still up 500% to 1000% from early 2020, and medical PPE is required in more than just global pandemics. Simply put, the need for domestically produced PPE isn’t going anywhere; if anything, it’s only going to be more critical in the months and years to come.

The domestic PPE manufacturing supply chain has never been stronger, but it takes a long-term commitment to ensure security in the future. With 510(K) clearance, Wildcat PPE has taken a bold step toward that secure future, completing the FDA’s full vetting process for our Made in Texas AAMI Level 3 full back isolation gowns.

How Our 510(K) Clearance Helps America’s Medical Workers

The FDA’s EUA was critical to boosting PPE manufacturing quickly as the COVID-19 emergency unfolded. However, these authorizations are designed to be temporary, and they’ll eventually expire. By securing the FDA’s 510(K) clearance for our full back gowns, we’re able to continue producing our Made in Texas PPE permanently. This is good for our current customers, our domestic supply chain partners and, most importantly, our nation’s medical workers—all of whom rely on Wildcat PPE to continue manufacturing the highest quality PPE.

The 510(K) clearance process for PPE is tedious, and for good reason: so many American workers rely on personal protective equipment to ensure their health and safety. PPE must meet the highest possible standards. But this Herculean effort also provides tremendous value to everyone who relies on Wildcat PPE. The FDA has validated our unmatched manufacturing quality, and we’re now able to have guaranteed longevity as a trusted source for Made in Texas PPE.

The product that received 510(K) clearance, our AAMI Level 3 full back isolation gown, is used primarily to protect frontline healthcare workers from contracting diseases. It guards against COVID-19, but it’s also critical for other conditions that will outlast this pandemic. We’re the first U.S. PPE manufacturer to secure clearance, and it will enable us to continue serving America’s medical workers into the future.

If your organization’s medical workers need high-quality domestically produced PPE, we’re ready to answer the call. Learn more about our 510(K) cleared full back isolation gown. Then, explore our full line of Made in Texas PPE, all designed to keep our nation’s medical workers safe during the pandemic and beyond.