CURAD CUR8104Recalls & reported problems

Medline Industries, Inc. · GLOVE,EXAM,LATEX,CURAD,PF,SM · Class 1

All models of CURAD (85)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00080196319186), received between Aug 31, 2026 and Sep 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Split, Cut or Torn3
Material Puncture/Hole1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 22, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was reported that gloves are tearing at cuff.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858634 ↗
MalfunctionSep 1, 2026Material Split, Cut or Torn
It was reported that GLOVES ARE FALLING APART WHEN PLACING THEM ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549206 ↗
MalfunctionAug 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533235 ↗

Device details

UDI-DI	`00080196319186`
Brand	CURAD
Model	CUR8104
Company	Medline Industries, Inc.
Product code	LYY · Latex patient examination glove
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 27, 2026

Device type (GMDN): Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Other Latex patient examination glove devices

CURAD CUR8105
Medline Industries, Inc. · Latex patient examination glove
3 reports
CURAD CUR8106
Medline Industries, Inc. · Latex patient examination glove
1 report

All Latex patient examination glove devices →

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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