Skip to content

FLEXAL 88FS03MRecalls & reported problems

Cardinal Health 200, LLC · Nitrile Exam Gloves Flexal Comfort · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20885380166317), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Reaction1

Recent adverse event reports

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

  • InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER ALLEGEDLY THE EMPLOYEES¿ HANDS ARE BREAKING OUT DUE TO USING THE GLOVES. THE EMPLOYEE WAS REPORTEDLY SEEN BY HER PHYSICIAN AND PRESCRIBED TRANSDERMAL STEROID CREAM.

    Patient problems: Reaction

    MAUDE report 10502763 ↗

Other Patient examination glove, specialty devices

All Patient examination glove, specialty devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.