FDA grants Showa Group nitrile gloves 510(k) medical approval

Fayette, AL – SHOWA Group announced that its single-use nitrile gloves have been granted FDA 510(k) medical approval. As the only integrated manufacturer of nitrile, single-use PPE gloves with full U.S. onshore capabilities, SHOWA Group is now able to deliver the market’s first biodegradable nitrile gloves approved for medical use.

Reliance on overseas PPE suppliers during the pandemic created a perfect storm for healthcare organizations when supply chain breakdowns, crippling delays, price gouging and inferior products put the safety of medical professionals and patients at risk. With SHOWA’s FDA 510(k) approval, hospitals, Group Purchasing Organizations (GPOs) and other healthcare buyers can purchase medical gloves certified as safe and effective for frontline workers.

“Through our Fayette, Alabama glove manufacturing capacity and strategic partnership with Zeon Chemicals that enabled us to secure the lone domestic capability of nitrile butadiene latex, SHOWA stands alone as the only U.S. domestic manufacturer of FDA-cleared, Berry Amendment-compliant Made in America medical PPE gloves,” said Richard Heppell, President and COO, SHOWA Group. “This means that every aspect of our medical glove production – from manufacturing to raw materials to packaging – is 100% sourced in the U.S. and available today for healthcare buyers seeking to end their reliance on Asia suppliers.”

SHOWA Group RAQA Manager / Technical Manager Brian Moseley adds: “SHOWA launched its biodegradable nitrile gloves a decade ago as an industry first, and since that time we’ve continued to invest in technology that reduces the environmental impact of PPE glove waste – a huge challenge with medical PPE during the pandemic. It can take 100 years or more for regular nitrile gloves to decompose in landfill conditions, but with SHOWA’s Eco Best Technology we’ve dramatically reduced decomposition time.”

In February, SHOWA Group announced a major expansion to its Fayette, Alabama manufacturing facility that will increase SHOWA’s annual domestic production capacity to 1.2 billion gloves by the end of 2022, and 2.8 billion 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 U.S. is better prepared for future pandemics.