FDA Approves Reusable Gown for Healthcare Settings

Richard Gawel

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The Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Richmond Dental and Medical reusable AAMI PB70 Barrier Protection Level 1 isolation gown for use as personal protective equipment (PPE) in healthcare settings. The gown’s fabric is a 65%/35% polyester/cotton blend made in the United States, with cutting and sewing in Mexico and Nicaragua.

Compared to disposable PPE gowns, Richmond said, its gowns are more economical at less than 30 cents per wear through a hundred home launderings. They also are eco-friendlier and more reliable in terms of the supply chain, according to the company, as well as softer and more comfortable.

Noting that these gowns are AAMI Level 1 certified, Richmond said that more than 53% of isolation gowns from global suppliers fail to meet US standards. Further, the ECRI Institute has warned that purchasing gowns that do not meet AAMI/ANSI standards may put healthcare employees at risk.

“We’re excited to better serve healthcare workers in a time of great need,” said Brad Fekete, executive vice president of sales and marketing. “With so much strain placed on the health sector right now, the last thing companies should have to worry about is whether or not their supplier is reliable. Richmond is a supplier that you can trust, with a 125-year reputation for quality.”

The gown can be laundered a hundred times in a home washer or 25 times at a commercial laundry. The kimono-style garment, with elastic sleeve ends that use natural rubber latex, is not effective for the prevention or treatment of COVID-19 but has received EUA from the FDA due to PPE shortages.

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