A Louisiana company has received FDA clearance for its chemo-rated nitrile exam gloves to be used in health care. SafeSource Direct partner Steve Mott says the approval positions the company to meet the demand to help keep healthcare workers safe.
“ A number of tests that they’ve put in place that establish the quality of your product so that when you’re selling it into health care they know that the front line worker is protected,” Mott said
SafeSource Direct, LLC, is located in Broussard, Louisiana. Mott says the company has been supplying gloves to general manufacturing companies while it awaits FDA approval. Mott says SafeSource Direct was founded in January 2021 as a joint venture between Ochsner Health and Trax Development in response to disruptions in the world wide supply chain, which affected the supply of medical equipment.
“When you go through a pandemic, any kind of geopolitical problem, shipping restraints, congestion, that all puts that supply chain at risk,” Mott said.
More than 90 percent of medical-grade nitrile gloves are manufactured outside the US. Mott said SafeSource can currently produce 108,000 gloves per hour, and the expansion will mean it will be able to produce more than 2 billion gloves annually.
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. The company also makes shoe covers and will soon be making N95 respirators, hair bouffant head covers, and isolation gowns.
Mott says the FDA approval will mean the addition of more than 1300 jobs to the facility, which already employs more than 850 people—all of them in Louisiana.
“Our nitrile gloves will be not just American made, they’ll be 100 percent Louisiana made which is pretty cool, Mott said, and added, “We will get all the raw materials domestically from Louisiana and then we will manufacture them here.”
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