Halyard 47375Recalls & reported problems
O&M Halyard, Inc. · SKYBREEZE* Powder-Free Nitrile Exam Gloves, M · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651473756), received between May 11, 2026 and May 11, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Component Incompatible” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Component Incompatible2
Patient problems
- Local Reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2026Component Incompatible
THE NURSE EXPERIENCED INTENSE ITCHING AND REDNESS AFFECTING THE FINGERS, PALMS, BACKS OF THE HANDS, AND WRISTS. THE REACTION OCCURRED DURING THE FIRST USE, WITHIN THE FIRST TWO HOURS OF WEAR. NO MEDICAL TREATMENT WAS REQUIRED, AND THE SYMPTOMS RESOLVED WITHOUT INTERVENTION. THE NURSE HAS HAD SIMILAR REACTION IN THE PAST WITH PLASTIC GLOVES; HOWEVER, NEVER WITH OTHER BRANDS OF NITRILE GLOVES.
Patient problems: Local Reaction
MAUDE report 25135111 ↗InjuryMay 11, 2026Component Incompatible
AFTER APPROXIMATELY 10 MINUTES OF GLOVE USE, THE WEARER DEVELOPED SIGNIFICANT ITCHING AND REDNESS ON THE HANDS AND DISCONTINUED USE. ALTHOUGH THE WEARER HAS A KNOWN ALLERGIC PREDISPOSITION, NO SIMILAR REACTIONS HAVE BEEN REPORTED WITH NITRILE GLOVES FROM OTHER MANUFACTURERS PREVIOUSLY USED. THE NURSE LATER CONSULTED A DERMATOLOGIST FOR AN UNRELATED CONCERN AND MENTIONED THE REACTION; HOWEVER, NO TREATMENT OR PRESCRIPTION WAS PROVIDED. DOCTOR SUGGESTED FURTHER TESTS, HOWEVER, NURSE DECLINED.
Patient problems: Local Reaction
MAUDE report 25135106 ↗
Other Patient examination glove, specialty devices
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- PremierPro D5062Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5065Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5063Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- Halyard 55090O&M Halyard, Inc. · Patient examination glove, specialty2 reports
- FLEXAL 88FS03MCardinal Health 200, LLC · Patient examination glove, specialty1 report
- Halyard 55082O&M Halyard, Inc. · Patient examination glove, specialty1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.