MEDLINE 4GVINSCRecalls & reported problems

Medline Industries, Inc. · GLOVE, EXAM, 4G VINYL, CHEMO, PF, LF, S · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20193489081586), received between Aug 7, 2026 and Aug 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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

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

Most reported problems

Device problems

Material Puncture/Hole1
Material Split, Cut or Torn1

Patient problems

Exposure to Body Fluids1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 7, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was reported that, 4G exam gloves have holes which lead to strike through and tearing during patient care. Staff exposed to patient fecal fluid, blood and drugs. Also shows thin spots in gloves.
Patient problems: Exposure to Body Fluids
MAUDE report 50181413 ↗

Device details

UDI-DI	`20193489081586`
Brand	MEDLINE
Model	4GVINSC
Company	Medline Industries, Inc.
Product code	LYZ · Vinyl 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	Feb 19, 2026

Device type (GMDN): Vinyl examination/treatment glove, non-powdered

A non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

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All Vinyl 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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