Medline TRG400MRecalls & reported problems
Medline Industries, Inc. · GLOVE, EXAM, NITRILE, PF, LF, M · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888277400583), received between May 5, 2026 and Sep 22, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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
- Material Split, Cut or Torn6
- Patient-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Skin Inflammation/ Irritation2
- Discomfort1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Split, Cut or Torn
It was reported that "Gloves are ripping."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852623 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
It was reported that she purchased gloves that came in torn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752189 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675072 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
It was reported that, upon removal from the box, the glove is torn from the cuff to the base of the fingertips in two places.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181418 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
It was reported that upon removal from the box, the glove has a broken fingertip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50178713 ↗InjuryMay 15, 2026Patient-Device Incompatibility
ACCORDING TO THE FACILITY A TEAM MEMBER EXPERIENCED IRRITATION ON BOTH HANDS AFTER USING THE PRODUCT. CORTISONE CREAM WAS APPLIED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25192794 ↗InjuryMay 13, 2026Patient-Device Incompatibility
ACCORDING TO THE FACILITY, "A TEAM MEMBER EXPERIENCED IRRITATION" AND "HAS DEVELOPED VISIBLE RASHES ON BOTH HANDS" AFTER USING THE PRODUCT.
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation
MAUDE report 25161843 ↗MalfunctionMay 5, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE GLOVES SEEM TO BE TEARING EASIER THAN NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088928 ↗
Other Polymer patient examination glove devices
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- Bosma Enterprises 72-50903Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50902Bosma Enterprises · 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 47460O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50900Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.