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Home » Showa Group Receives FDA’s 510(k) Approval for Biodegradable Nitrile Glove
Showa Group Receives FDA’s 510(k) Approval for Biodegradable Nitrile Glove
Fayette, Ala.-based Showa Group’s single-use nitrile gloves have been granted the FDA’s 510(k) marketing clearance.
The company claims to be the only U.S. domestic manufacturer of FDA-cleared, Berry Amendment-compliant medical gloves. The Berry Amendment requires the Department of Defense to give preference in procurement to domestically manufactured products.
The FDA’s 510(k) clearance covers Showa’s M7005PF single-use line of nitrile gloves that are low-risk Class I devices. The gloves are fully biodegradable, breaking down by 82 percent in 386 days when tested in a laboratory. They are also powder-free and pose no risk to people who suffer from a natural rubber allergy.
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