FLEXAL 88TN02SRecalls & reported problems
Cardinal Health 200, LLC · Nitrile Exam Gloves Flexal · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20885380137119), received between Apr 27, 2017 and Feb 28, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Burning Sensation1
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED WEARING GLOVES AND AFTER TAKING THEM OFF, NURSE HANDS STARTED BURNING/ITCHING AND TURNING SPLOTCHY RED. ONLY ONE NURSE HAD TO SEE AN ALLERGIST FOR MEDICATIONS. NO PATIENT DEMOGRAPHIC OR INFORMATION ABOUT TYPE ON MEDICATION WERE PROVIDED BY THE CUSTOMER.
Patient problems: Burning Sensation
MAUDE report 13625376 ↗InjuryApr 27, 2017Insufficient Device Problem Information
BASED ON THE REPORT RECEIVED BY THE CUSTOMER AN EMPLOYEE WENT TO EMPLOYEE HEALTH ON (B)(6) 2017 AND THEN TO THE EMERGENCY ROOM ON (B)(6) 2017 DUE TO CONTACT DERMATITIS. SHE WAS GIVEN HYDROCORTISONE AND BENADRYL BY ER.
Patient problems: Inflammation
MAUDE report 6525560 ↗
Other Polymer patient examination glove devices
- Good Works 72-50602Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 47461O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- 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.