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PremierPro D5064Recalls & reported problems

Prestige Ameritech, Ltd. · PremierPro Plus Powered by Honeywell Nitrile Exam Glove Large 200count · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 13, 2024Open, Classified

    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).

    Z-2320-2024 · Root cause: Under Investigation by firm · FDA record ↗

Other Patient Examination Glove, Specialty devices

All Patient Examination Glove, Specialty devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.