Hand protection company SHOWA Group reported on Thursday the receipt of the US FDA's 510(k) medical approval for its Class I Medical device, M7005PF single-use first biodegradable nitrile gloves for medical use.

Based on the SHOWA's Eco Best Technology (EBT), M7005PF is fully biodegradable, breaking down by 82% in just 386 days when tested in a laboratory. The gloves' additional key product benefits and features include increased dexterity and flexibility, powder-free, excellent tensile strength, no natural rubber allergy risks as well as leak and tear resistant.

Following the US FDA 510(k) approval, the hospitals, Group Purchasing Organizations (GPOs) and other healthcare buyers can purchase the company's medical gloves certified as safe and effective for frontline workers.

At the Fayette, Alabama manufacturing facility, the company will increase its annual domestic production capacity to 1.2bn gloves by the end of 2022 and 2.8bn gloves once the buildout is complete. The expansion strengthens the country's domestic supply of medical PPE and reduces reliance on overseas PPE to ensure the US is better prepared for future pandemics.