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PremierPro 5063Recalls & reported problems

Prestige Ameritech, Ltd. · PremierPro Plus Improved Thinner Technology Nitrile Exam Glove Medium 200count · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818566011022), received between Aug 23, 2019 and Aug 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 23, 2019Material Split, Cut or Torn

    GLOVE TORE WHEN PUTTING ON DURING CASE. RECURRING PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8926207 ↗

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.