FLEXAL 88TT21SRecalls & reported problems
Cardinal Health 200, LLC · Nitrile Exam Gloves Flexal Feel · 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 20885380135917), received between Nov 28, 2019 and Nov 28, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Emits Odor” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Emits Odor1
Patient problems
- Reaction1
- Skin Discoloration1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2019Device Emits Odor
CUSTOMER REPORTED A BOX OF EXAM GLOVES APPEARED TO CONTAIN A STRONG CHEMICAL ODOR, AND THAT SEVERAL EMPLOYEES WERE HAVING SKIN REACTIONS AFTER USING THEM. REPORTEDLY, ONE EMPLOYEE EXPERIENCED SYMPTOMS OF DISCOLORATION, RESEMBLING EARLY STAGE BLISTERING, BUT NO FORMATION OF BLISTERS. ALL INVOLVED SUPERVISORS WERE NOTIFIED OF THE CONCERN, AND ADVISED TO HAVE THEIR STAFF INSPECT ALL GLOVES PRIOR TO USE, AND TAKE ANY SUSPECTED CONTAMINATED GLOVES OUT OF SERVICE. THE STRONGEST ODOR HAS BEEN IDENTIFIED AS THE FLEXAL FEEL GLOVE, BUT THE ODOR IS NOTICEABLE AMONG ALL SIZES AT A LESSER DEGREE.
Patient problems: Reaction; Skin Discoloration; Swelling
MAUDE report 9390482 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.