FDA-Device2024-07-17Class II
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.
SVS LLC
Hazard
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).
Sold states
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Affected count
155,540 inner boxes
Manufactured in
13034 Ballantyne Corporate Pl, N/A, Charlotte, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2024Don't want to check this manually?
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