Fayette-based Showa Group has earned FDA 510(k) approval for its biodegradable medical-grade gloves.
Showa has been the only U.S. maker of nitrile gloves for some years. But the firm came to national attention in the early days of the COVID-19 pandemic when personal protective gear — mostly sourced overseas — was in short supply.
“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.”
Moreover, the gloves qualify as biodegradable, breaking down by 82% in a little more than a year in laboratory tests.
“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,” said Brian Moseley, who is RAWA and technical manager at Showa. “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.”
Showa is in the midst of a major expansion that will bring its capacity to 1.2 billion gloves a year by the end of 2022 and to 2.8 billion gloves a year when the expansion is complete.
