Trash talk: FDA goes green with nod for biodegradable medical gloves

The healthcare field is estimated to generate more than 5 million tons of waste every year—an issue that the COVID-19 pandemic further compounded, producing tens of thousands more tons of personal protective equipment and plastic-based diagnostic test kits around the world.

One of the key contributors to healthcare’s sustainability challenge is the fact that so much of the industry’s materials must be single-use for safety purposes. Amid growing concern over the environmental impact of humans and our endless piles of trash, however, many manufacturers of medical equipment and devices have set themselves the task of finding ways to cut back on waste while still maintaining safety standards.

A chief example is the introduction of biodegradable materials into medtech development, a strategy that recently received a vote of confidence from the FDA.

Showa Group announced Thursday that its biodegradable, single-use nitrile medical gloves have received 510(k) clearance.

The newly cleared gloves are powder-free, resistant to leaks and tears, and because they’re made with nitrile butadiene latex, won’t trigger allergies to natural rubber latex.

In lab tests, the gloves were shown to break down by more than 80% in an average of 386 days. Full decomposition is estimated to occur after one to five years in active landfills, compared to the decades it takes regular nitrile gloves.

They’re made biodegradable by the addition of Showa’s Eco Best Technology, which it first introduced a decade ago in 2012 and has since applied to a broad slate of its gloves. The FDA clearance includes only the M7005PF model, a 4-millimeter blue glove with textured fingertips that comes in a range of four sizes.

Other biodegradable gloves have been given the agency’s OK, but because the Georgia-based company manufactures all the gloves at its Alabama facility and sources its nitrile butadiene latex from Kentucky’s Zeon Chemicals, Showa is the only fully U.S.-based manufacturer of biodegradable gloves, according to Richard Heppell, its president and chief operating officer.

Showa notes on its website that “virtually all nitrile gloves are made in Asia.” Meanwhile, only about 1% are made elsewhere, including those churned out from the facility in Fayette, Alabama.

In February, Showa announced plans to expand the facility. Backed by more than $80 million in contracts from the U.S. Department of Health and Human Services and $35 million from its own coffers, the expansion is expected to triple Showa’s glove production, which is slated to reach 1.2 billion gloves per year by the end of 2022 and 2.8 billion when construction is complete in the fall of 2024.

The company’s expanded manufacturing abilities and “Made in America” status are meant to help reduce the need for U.S. healthcare providers to source medical equipment from overseas—a situation that led to severe shortages and price gouging amid the COVID pandemic. As an added bonus, sourcing materials from domestic manufacturers helps cut down on the carbon emissions and other environmental costs associated with international shipping.