Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

Recall Insight

This FDA Devices action (record #Z-2320-2024) was formally reported on July 17, 2024, with the manufacturer initiating the action on May 13, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Svs LLC is listed as the recalling firm, operating out of Charlotte, NC. Federal records list the affected scope as 155,540 inner boxes.

The documented reason for this recall is: Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner b… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.