MEDLINE FG3001Recalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,NITRILE,FG TOUCH, 300, S · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888277362737), received between May 16, 2026 and Sep 28, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn25
- Inadequacy of Device Shape and/or Size1
- Material Integrity Problem1
- Patient-Device Incompatibility1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Rash1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916787 ↗MalfunctionSep 21, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840062 ↗MalfunctionSep 14, 2026Material Integrity Problem; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758835 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
It was reported that "gloves are torn upon removing them from box."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756316 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
It was reported that the gloves tear easily.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754572 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702320 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699032 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696357 ↗MalfunctionSep 7, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652165 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566107 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
It was reported that "Product was torn prior to use; three boxes from the same lot were affected."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545954 ↗MalfunctionAug 31, 2026Inadequacy of Device Shape and/or Size
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531176 ↗MalfunctionAug 31, 2026Material Split, Cut or Torn
It was reported that "THESE GLOVES ARE RIPPING RIGHT WHEN THEY PUT THEM ON. ALSO THEIR SCOPE CLEANER WAS WASHING A DIRTY SCOPE AND HER GLOVE FILLED WITH WATER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524953 ↗MalfunctionAug 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522903 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229477 ↗InjuryJul 31, 2026Patient-Device Incompatibility
It was reported that on (b)(6)2026 the individual had an "allergic reaction" described as a "rash" after using the product. Per the customer, the individual required "steroid cream" to treat the skin reaction.
Patient problems: Rash
MAUDE report 50098626 ↗MalfunctionJul 27, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040127 ↗MalfunctionJul 10, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788023 ↗MalfunctionMay 28, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT; GLOVES OFTEN TEAR WHEN DONNING. RIPPED GLOVES WERE DISCARDED AND ANOTHER PAIR WERE DONNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325772 ↗MalfunctionMay 20, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, UPON CLINICAL STAFF APPLICATION, GLOVE RIPS APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236655 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, GLOVES ARE RIPPING EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196777 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, GLOVES ARE RIPPING EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196774 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, GLOVES RIPPED WHILE NURSE DONNED FOR PERSONAL PROTECTION EQUIPMENT. GLOVES WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196511 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, BEING USED AS PERSONAL PROTECTIVE DEVICE. THE GLOVES RIP EASILY UPON DONNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196507 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, THE GLOVES RIP EASILY UPON DONNING. GLOVE DISCARDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196506 ↗
Other Polymer patient examination glove devices
- Halyard 48774O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 48773O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50803Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 48771O&M Halyard, Inc. · 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
- Halyard 47462O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50903Bosma Enterprises · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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