Recall Z-2320-2024 ยท LZC Medical Glove, Specialty
SVS LLC
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.
| Date | Jul 9, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified via email on 05/13/2024. The consignees are instructed to discontinue using PremierPro PlusTM D506X series exam gloves; Notify end-users of this voluntary recall notification and discontinue use of the products within your healthcare facilities; Remove these products from areas where they may be available including all points of care, supply part locations, and central supply warehouses; Return the products within Table A above to the firm at the firm's expense. All returns of the above-listed products will be replaced by S2S Global with internationally-sourced Premier |
| Quantity | 155,540 inner boxes |
| Distribution | US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves American Nitrile Operations, LLC, Jul 8, 2022 |