PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: July 17, 2024 Initiated: May 13, 2024 #Z-2320-2024

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.

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).

Details

Recalling Firm
SVS LLC
Units Affected
155,540 inner boxes
Distribution
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Location
Charlotte, NC

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by SVS LLC. Units affected: 155,540 inner boxes.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2320-2024.

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