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.