Halyard 50602Recalls & reported problems
O&M Halyard, Inc. · HALYARD* PURPLE NITRILE-XTRA* Powder-Free Exam Gloves, M · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651506027), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Respiratory Distress1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION TO THE NITRILE GLOVES AND EXPERIENCED SHORTNESS OF BREATH. ADDITIONAL INFORMATION RECEIVED ON 17-JAN-2017 THAT STATED, "A NURSE USED GLOVES TO DELIVER MITOMYCIN CHEMO DRUG TO THE PHYSICIAN. THE NURSE ONLY DELIVERED THE CHEMO DRUG, NOTHING ELSE. SHORTLY AFTER PUTTING GLOVES ON THE NURSE NOTICED A BURNING ON/AROUND THE FINGERS THAT QUICKLY SPREAD TO THE NURSES ARMS IN THE FORM OF A RASH. IT WAS THE FIRST TIME THE NURSE USED THESE GLOVES. THE NURSE WAS TAKEN TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH, AND WAS NEARLY/BUT NOT INTUBATED." NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Respiratory Distress
MAUDE report 6298620 ↗
Other Patient examination glove, specialty devices
- PremierPro D5061Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5064Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5063Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5062Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5065Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- Halyard 55090O&M Halyard, Inc. · Patient examination glove, specialty2 reports
- Halyard 47375O&M Halyard, Inc. · Patient examination glove, specialty2 reports
- PremierPro 5063Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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