SafeSource Direct Receives FDA 510(k) Clearance on Chemo-Rated Nitrile Exam Gloves
FDA Clearance Clears Way for American-Made PPE
November 17, 2022
BROUSSARD, La. – SafeSource Direct, LLC, the maker of high-quality, American-made personal protective equipment (PPE), announced today that its chemo-rated nitrile exam gloves have received FDA 510(k) clearance. The determination follows extensive testing and clears the way for the gloves to be used in healthcare.
“This marks a tremendous step toward U.S. supply resilience as healthcare providers look to mitigate risks in sourcing critical supplies,” said Justin Hollingsworth, CEO, SafeSource Direct. “While COVID-era shortages and substandard products may seem like things of the past, the risk that our nation’s healthcare providers find themselves in a similar situation remains very real. That’s why we’re offering a solution that sidesteps the supply interruptions and lack of quality control that come with dependence on foreign manufacturers.”
Hollingsworth says SafeSource Direct is ready to meet the nation’s demand to keep people safe. With two state-of-the-art facilities in Broussard, Louisiana, it has multiple operational production lines capable of manufacturing 108,000 gloves per hour. The company aims to have a dozen lines operational by January 2024 capable of producing over 2 billion gloves annually with additional manufacturing capacity available on-site. As the company expands its capacity over the coming months, it will be among the largest manufacturers of chemo-rated nitrile exam gloves in America- if not the largest.
In addition to gloves, SafeSource Direct produces Level 1 and 3 surgical ear loop and surgical tie masks and standard three-ply Level 1 and 3 procedure masks, which received FDA 510(k) clearance in May. It also makes shoe covers and will soon be making N95 respirators, hair bouffant head covers, and isolation gowns.
With SafeSource Direct’s rapid expansion has come more than 850 American jobs, with 2,200 total expected over the coming months.
“One hundred percent American owned, American operated, and on American soil– we’re uniquely positioned to help solve America’s PPE supply challenges,” Hollingsworth said.
SafeSource Direct also stands out through its partnership with the Gulf South’s largest health system, Ochsner Health. Created as a joint venture between Ochsner and Trax Development during the COVID-19 pandemic, SafeSource Direct is the only PPE manufacturer that is U.S. provider-owned with U.S. provider-owned quality control.
“Throughout the pandemic, we had to innovate, and as a result, we believe we’re better prepared for the next public health crisis or global supply shortage,”said Aimee Quirk, CEO, Ochsner Ventures, Ochsner Health. “This is a long-term, sustainable solution to mitigate risks inherent in the global supply chain.”
“Since COVID, we’ve seen the spread of additional dangerous infectious diseases, inflation, and numerous global conflicts. These types of situations will continue to emerge and disrupt supply,” said Regine Villain, System Vice President of Supply Chain Network and Chief Supply Chain Officer, Ochsner Health. “That’s why we decided to take matters into our own hands with an onshore company that can meet our nation’s PPE supply needs.”
She said purchasing from SafeSource Direct also aligns with the healthcare system’s environmental, social, and governance (ESG) priorities. “Buying from SafeSource Direct eliminates the carbon emissions associated with shipping containers around the world, and it ensures that our products are not only high quality but also manufactured ethically,” said Villain.