PROTEXIS 2D72PT65XRecalls & reported problems
Cardinal Health 200, LLC · Sterile Polyisoprene Powder-Free Surgical Gloves · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380031939), received between Jul 16, 2020 and May 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Mar 15, 2022Completed
Product was distributed without being sterilized.
Z-0902-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- Exposure to Body Fluids1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Material Separation; Material Separation
CUSTOMER REPORTED A HOLE IN GLOVE; SPLIT INTO TWO PIECES. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119245 ↗MalfunctionJul 16, 2020Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY, THE SURGEON¿S GLOVE TORE CAUSING HIM CONTACT WITH THE PATIENT'S BLOOD WHICH WAS POSITIVE FOR (B)(6). THE SURGEON PERFORMED IMMEDIATE CLEANING AND DISINFECTION OF THE SKIN AREA IN CONTACT WITH BLOOD. MINIMAL DELAY IN PROCEDURE. THE SURGEON DID NOT REQUIRE FOLLOW UP LAB TESTING OR MEDICATIONS. NO INJURY REPORTED TO THE PATIENT. NO FURTHER ISSUES REPORTED FROM SURGEON.
Patient problems: Exposure to Body Fluids
MAUDE report 10286067 ↗
Other Surgeon's gloves devices
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- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685255Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685260Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685275Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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