Medical Device Recall: 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
SVS LLC · May 13, 2024
Reason for Recall
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 box indicating another size).
Product Description
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.
Distribution
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
States Affected
NATIONWIDE
Quantity Affected
155,540 inner boxes
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2320-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.