FAYETTE, Ala.--(BUSINESS WIRE)--SHOWA Group today 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.”
FDA 510(k) clearance extends across the SHOWA M7005PF single-use nitrile glove product line. M7005PF is a Class I Medical device (glove) intended for medical purposes in medical exams or any environment where the examiner and patient require protection from contamination. By using SHOWA’s Eco Best Technology® (EBT), M7005PF is fully biodegradable, breaking down by 82% in just 386 days when tested in a laboratory.
Additional key product benefits and features include:
- Increased dexterity and flexibility
- Excellent tensile strength
- No natural rubber allergy risks
- Leak and tear resistant
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.
To learn more about how SHOWA is meeting the demand for COVID-19 PPE with medical-grade gloves that are manufactured and distributed in the U.S., visit https://www.showagroup.com/us-en/medical-examination.
SHOWA is synonymous with the highest degree of hand protection and innovation. We pioneer revolutionary technology and create over 1,800 gloves, each meticulously engineered to provide the perfect protection for the task at hand. With 58 patents owned and more than 100 researchers and developers dedicated to making our best even better, we blaze a trail for our industry without imitation. SHOWA’s unparalleled quality is achieved through 100% integrated manufacturing, giving us complete control at every stage of design and production. Down to every fiber, our gloves are created better to perform better, unleashing new potential for hands at work. Visit https://www.showagroup.com to learn more.