Stronghold Group Receives First 510(k) for Nitrile Examination Gloves
PHILADELPHIA, PA / ACCESSWIRE / June 15, 2022 / Stronghold Group, whose globally experienced team of Iraq and Afghanistan war veterans offers a comprehensive line of high-quality PPE products, has received its first 510(k) for its nitrile medical examination gloves, K213859. The President and CEO of Stronghold Group, David Henderson, states that the company will produce the gloves both within the United States and overseas as part of its plans to migrate the manufacturing base away from China.
According to David Henderson, "We'll offer the American consumer a competitively priced foreign product as well as a product made in the United States. Both options provide supply chain risk mitigation at a time when American medical supplies markets need it most. Over-reliance on overseas medical products manufacturing created a perfect storm for healthcare providers, who had to operate in the face of supply chain breakdowns, crippling delays, price gauging, and sub-standard products from ad-hoc facilities."
In the past, Stronghold has provided its customers with real-time shipment tracking by arming containers with GPS trackers as a way to provide its customers with transparency. According to David Henderson, "The importance of supply chain transparency is growing as shipping delays and quality issues have seemingly become the norm throughout COVID. We're driven to provide transparency and reduce supply chain risk. Frankly, our country is faced with extremely serious national security implications resulting from supply chain concentrations in opaque overseas markets, and we're doing our part to help."
Founded in 2015, Stronghold Group primarily serves the federal government, including Health and Human Services (HHS), Veteran Affairs (VA), Defense Logistics Agency (DLA), Defense Health Agency (DHA), and several other federal agencies. Having served in the Army and overseas, Stronghold Group's co-founders experienced federal contracts firsthand and decided to use their expertise to become a sales and distribution arm of medical products for the federal government. With its 510(k) for nitrile examination gloves, Stronghold Group aims to equip more federal agencies as well as civilian medical professionals with PPE and medical products. The goal is to help relocate a $9B/year industry that until now has largely been in overseas markets that provide little transparency, such as China and Malaysia.
"During the pandemic, one of the biggest issues was that medical professionals who needed PPE were very reliant on China's supply chain," says Henderson. "Some hospitals were overwhelmed with COVID patients and lacked gloves to protect their healthcare workers, and shipments from China took up to 90 days to arrive - or more. Often, the shipments were stopped at Chinese ports, creating further delays. We want to help prevent this problem in the future by manufacturing nitrile gloves here in the United States. We hope that this will speed shipment times, create less waste, and allow hospitals to have more control over their inventory and budgets. We want them to be able to focus more on patient care and less on inventory control."
Stronghold Group is also excited to announce that their own 510(k) nitrile glove, isolation gowns (product code OEA), and surgical are gowns (product code FYA) are already being manufactured in America and will soon start delivering to U.S. Federal Customers through their VA Federal Supply Schedule (FSS) contract award. "There seems to be this narrative that the U.S. can't compete anymore in the manufacturing and innovation space," says Henderson. "But I think that's just not true. We have sent people to the moon. We created the lithium car battery. We 3D print revolutionary implants. American ingenuity knows no bounds. That's the America I believe in."
As part of its plans to make the United States a center of PPE, medical products, and pharmaceutical manufacturing, Stronghold Group also recently opened its warehouse/distribution facility in Dallas, Texas. The company explains that as Dallas is centrally located, it was the logical choice for the company's operations.
"Dallas is perfectly positioned for our distribution and enjoys daily flights for all major airlines, not to mention it is just a day's drive from the port in Houston," Stronghold Group states. "It also is the nexus of numerous trucking routes, so logistically, it made sense for us to base our facility here."
The company has submitted three additional applications for 510(k) products that it aims to eventually distribute through its new facility. "Once our 510(k)s are approved, we will be able to bring more products to market that have been developed based on specifications most desired by our medical professionals," says Stronghold Group. "We will be able to move ahead with our plans to manufacture more PPE and various medical products here in America, so we are looking forward to their approval."
Stronghold Group states that as 2022 continues, it will focus on contributing to the medical treatment that veterans receive. "As combat veterans ourselves, we are grateful for the opportunity to serve the veteran community," the company says. "The very least we can do for them at Stronghold Group is to ensure that their treatment teams have a reliable supply chain and the products they need."
Stronghold Group is a VA-verified, Service Disabled Veteran Owned Small Business (SDVOSB) comprised of Iraq-Afghanistan Veterans. Stronghold Group is a U.S.-based manufacturer and distributor of medical devices, personal protective equipment, and consumables to public and private healthcare entities, as well as federal, state and local agencies within the United States. Stronghold Group serves its customers through U.S. manufacturing facilities with a clear mission: to strengthen U.S. manufacturing footprint and capabilities, reduce reliance on overseas manufacturing, and increase the U.S. competitive posture through technological innovation and the U.S. labor market. Stronghold Group's globally experienced team of Iraq and Afghanistan war veterans has supported private companies and government/military agencies since 2016. Its services include assisting companies with obtaining 510(k)s, bringing their products to the federal marketplace, and consulting with private corporations to reduce supply chain risk.
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SOURCE: Stronghold Group
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