SafeSource Direct receives FDA clearance for American-made PPE

SafeSource Direct, created as a joint venture between Ochsner Health and Trax Development during the COVID-19 pandemic, is the only PPE manufacturer that is U.S. provider-owned with U.S. provider-owned quality control.

Business Announcement

OCHSNER HEALTH SYSTEM

 

IMAGE: FDA-APPROVED, CHEMO-RATED NITRILE EXAM GLOVES ARE BEING MANUFACTURED IN LOUISIANA BY SAFESOURCE DIRECT. THE COMPANY WAS CREATED AS A JOINT VENTURE BETWEEN OCHSNER HEALTH AND TRAX DEVELOPMENT DURING THE COVID-19 PANDEMIC. view more 

CREDIT: OCHSNER HEALTH

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 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. The company is also planning to become completely vertically integrated by sourcing raw materials in a nearby facility in Louisiana.

“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.

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About SafeSource Direct

SafeSource Direct LLC is an American manufacturer of personal protective equipment (PPE) dedicated to keeping our nation’s healthcare and other essential workers safe on the job. At SafeSource Direct, success minded team-members use innovation and automation to provide high-quality American-made PPE at prices competitive with those of foreign suppliers. Headquartered in Lafayette Parish, La., SafeSource Direct operates a state-of-the-art manufacturing plant in Broussard as well as in neighboring St. Martin Parish. Positioned near the Mississippi River, rail lines, and interstate highways, it is well positioned to distribute PPE to the nation. To learn more about how SafeSource Direct is laying the groundwork for sustainability in the healthcare industry, visit SafeSourceDirect.com.

About Ochsner Health

Ochsner Health is an integrated healthcare system with a mission to Serve, Heal, Lead, Educate and Innovate. Celebrating 80 years in 2022, it leads nationally in cancer care, cardiology, neurosciences, liver and heart transplants and pediatrics, among other areas. Ochsner is consistently named both the top hospital and top children’s hospital in Louisiana by U.S. News & World Report. The not-for-profit organization is inspiring healthier lives and stronger communities. Its focus is on preventing diseases and providing patient-centered care that is accessible, affordable, convenient and effective. Ochsner Health pioneers new treatments, deploys emerging technologies and performs groundbreaking research, including over 700 clinical studies. It has more than 36,000 employees and over 4,600 employed and affiliated physicians in over 90 medical specialties and subspecialties. It operates 47 hospitals and more than 370 health and urgent care centers across Louisiana, Mississippi, Alabama and the Gulf South; and its cutting-edge Connected Health digital medicine program is caring for patients beyond its walls. In 2021, Ochsner Health treated more than 1 million people from every state and 75 countries. As Louisiana’s top healthcare educator, Ochsner Health and its partners educate thousands of healthcare professionals annually. To learn more, visit www.ochsner.org.