SafeSource Direct secures FDA clearance for hospital-grade nitrile gloves

The FDA handed SafeSource Direct's chemo-rated nitrile gloves a 510(k) clearance Nov. 17, which company CEO Justin Hollingsworth said "marks a tremendous step toward U.S. supply resilience."

"One hundred percent American owned, American operated and on American soil — we're uniquely positioned to help solve America's PPE supply challenges," Mr. Hollingsworth said.

SafeSource Direct can manufacture 108,000 gloves per hour, and by January 2024, the company plans to be able to produce more than 2 billion gloves per year. 

"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," SafeSource Direct said in a statement. 

With its joint venture with New Orleans-based Ochsner Health, SafeSource Direct is the only PPE manufacturer that's U.S. provider-owned. The system's CEO of ventures, Aimee Quirk, said its partnership is a "long-term, sustainable solution to mitigate risks inherent in the global supply chain."

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