Kimberly-Clark to Pay Up to $40 Million to Resolve Criminal Charge Tied to Sale of Surgical Gowns

By Kelly Cloonan

Kimberly-Clark has agreed to pay up to $40.4 million to resolve a criminal charge relating to its sale of adulterated surgical gowns.

The Department of Justice said Thursday that a Kimberly-Clark employee conducted fraudulent testing on the company's MicroCool gowns to avoid submitting a premarket notification to the U.S. Food and Drug Administration after the company made a change to the gowns.

Kimberly-Clark continued to sell the gowns after the change without a new premarket notification, marketing the gowns as providing the highest level of protection against fluid and viruses, the DOJ said.

In total, Kimberly-Clark sold about $49 million worth of adulterated MicroCool gowns to customers in the U.S. and abroad, the DOJ said.

A U.S. District Court charged the Dallas-based company with one count of introducing adulterated surgical gowns into interstate commerce with an intent to defraud and mislead.

Premarket notifications aim to show the FDA that a medical device is as safe and effective as an already legally marketed device, the DOJ said. For U.S.-sold surgical gowns intended for surgeries and other high-risk medical procedures, the FDA requires that fluids be prevented from penetrating the gown.

The payment from Kimberly-Clark is to comprise a monetary penalty of $24.5 million, a forfeiture of $3.9 million in profit and up to $12 million in victim compensation.

As part of the resolution, the company has agreed to strengthen its compliance program and abide by reporting requirements.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

August 28, 2025 14:21 ET (18:21 GMT)