PROTEXIS 2D72PL75XRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380031786), received between Oct 24, 2019 and Jul 17, 2023 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Material Puncture/Hole; Material Puncture/Hole
CUSTOMER STATED A SURGICAL GLOVE BREACH OCCURRED DURING C-SECTION DELIVERY. SURGEON WAS FOUND TO HAVE A HOLE IN HER GLOVE DURING PROCEDURE. THE HOLE WAS NOTICED AFTER THE UTERUS AND FASCIA WERE CLOSED. SURGEON CONCERNED THAT PIECE OF GLOVE COULD HAVE BEEN LEFT INSIDE THE PATIENT. AS A PRECAUTION THE SURGEON OPENED THE ABDOMEN AND UTERUS BACK UP AND PERFORMED AN EXPLORATION AND IRRIGATION TO SEE IF SHE COULD FIND ANY PIECE OF THE GLOVE. NO PIECE OF A GLOVE WAS FOUND. THE PATIENT WAS PRESCRIBED IV ANCEF WHILE SHE WAS ADMITTED TO THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17337353 ↗MalfunctionOct 24, 2019Material Split, Cut or Torn
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE GLOVE FINGERTIP TORE ON THE PROTEXIS PI CLASSIC GLOVE DURING DR. (B)(6) PROCEDURE. THE GLOVE FINGERTIP WAS REPORTEDLY RETRIEVED IN THE PATIENT¿S CAVITY. PER THE CUSTOMERS INFORMATION THERE WAS NO ADVERSE EFFECTS TO THE SURGEON OR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9233485 ↗
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- 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
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
- 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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