The US Food and Drug Administration (FDA) has granted 510(k) clearance for SafeSource Direct’s chemo-rated nitrile exam gloves.
Following extensive testing, clearance was provided for the gloves to be used in the healthcare sector.
With multiple operational production lines, SafeSource Direct has two advanced facilities in Broussard, Louisiana.
These lines hold the capacity to manufacture 108,000 gloves per hour.
By January 2024, SafeSource plans to begin operations on a dozen lines to produce more than two billion gloves per annum.
The company is expected to become one of the largest manufacturers of chemo-rated nitrile exam gloves in America, as it is planning to expand its capacity over the coming months.
SafeSource Direct CEO Justin Hollingsworth said: “This marks a tremendous step toward US supply resilience as healthcare providers look to mitigate risks in sourcing critical supplies.
“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.”
SafeSource is also involved in the manufacturing of Level 1 and 3 surgical ear loop and surgical tie masks, and Level 1 and 3 procedure masks that secured 510(k) clearance in May.
The company, which also produces shoe covers, intends to soon manufacture N95 respirators, hair bouffant head covers, and isolation gowns.
SafeSource Direct also has a partnership with the Gulf South’s health system, Ochsner Health, which was formed by Ochsner and Trax Development during Covid-19.
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- Source: https://www.medicaldevice-network.com/news/fda-safesource-direct-nitrile-gloves/