Medline CUR4145RRecalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,NITRILE,PF,2CT INR,100CT,OSFM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884389108409), received between Jun 29, 2026 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn4
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950969 ↗MalfunctionSep 30, 2026Material Integrity Problem
It was reported that "The Nitrile quality is too thin. It immediately leaks and has been repetitively tearing when fitted on hands" and "the quality of material allows moisture to penetrate through or when putting them on my small to medium size hands they tear at the wrist."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950426 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918179 ↗MalfunctionSep 10, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722837 ↗MalfunctionJun 29, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, ABOUT 1/3 OF THE GLOVES RIPPED AT THE WRIST WHEN PUTTING THEM ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659924 ↗
Other Polymer patient examination glove devices
- Good Works 72-50603Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 47462O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 48774O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47460O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47463O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50903Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Good Works 72-50602Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 47461O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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