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AUTHOR: Nicolas Bykoff

“ The benefits extend beyond hand protection; the FDA 510(k) approval means that SHOWA has brought to market the first-to-market biodegradable medical nitrile glove using Eco Best Technology. ”

Doctors, nurses, and other healthcare professionals rely on nitrile gloves for most aspects of their daily work, in addition to COVID-specific testing and vaccinations. But not all nitrile gloves are approved for medical use, and even approved nitrile gloves sourced overseas can leave your healthcare organization vulnerable to the crippling PPE supply chain breakdowns that materialized through much of the pandemic.

The Medical-Grade PPE Rush

During acute supply shortages in the past year, sorting legitimate PPE purveyors from fraudulent operators was often a challenge for consumers and businesses. But in the medical industry, hospitals, group purchasing organizations (GPOs) and other buyers faced an even greater challenge in trying to source approved PPE, sometimes leaving frontline workers vulnerable. Medical-grade PPE glove production in particular is uniquely challenging because glove manufacturing is a complex, multi-year process.

When manufacturers onshore their supply chains, the result is a more resilient supply of nitrile medical gloves. That’s why domestically sourced medical PPE gloves – meaning gloves not just made in the USA, but manufactured end-to-end with American materials and equipment — are critical to protecting frontline healthcare workers and Americans.

SHOWA recently received FDA 510(k) approval across its 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.

The benefits of the FDA 510(k) approval

The benefits extend beyond hand protection; the FDA 510(k) approval means that SHOWA has brought to market the first-to-market biodegradable medical nitrile glove using Eco Best Technology. 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.

When GPOs or hospitals are searching for PPE suppliers, domestic manufacturers can offer medical gloves certified as safe and effective for healthcare professionals. By sourcing every aspect of medical glove production — from nitrile rubber to product packaging — from the U.S., SHOWA is investing in buying American and improving product availability.

Like much of the sterile or single-use equipment used in a healthcare setting, medical disposable gloves make up part of the larger concern around PPE waste. Until recently, no medically-approved gloves were available in biodegradable formulations, but the FDA’s approval of nitrile gloves with Eco Best Technology means SHOWA can now provide the medical industry with biodegradable gloves that can dramatically cut down on PPE waste in the long term.

Domestic PPE manufacturing requires substantial upfront investment, careful planning, and business relationships built over decades of trust to source quality materials and highly technical equipment entirely within the U.S.

 

SHOWA’s nitrile gloves are the first biodegradable gloves to receive 510(k) approval, and SHOWA is the only manufacturer in the US capable of producing FDA-approved domestically-sourced nitrile gloves at scale. To learn more about how SHOWA gloves are used in medicine visit SHOWA’s healthcare industry page.

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