PROTEXIS 2D72PT75XRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380031953), received between Apr 26, 2021 and Apr 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 Split, Cut or Torn1
- Use of Device Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2021Use of Device Problem; Material Split, Cut or Torn
TWO EVENTS HAVE BEEN REPORTED WITH SAME ISSUE. FIRST EVENT. REGISTERED NURSE (RN) PUT ON A PAIR OF THE ORANGE PROTEXIS PI STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES (SIZE 7 1/2), AND THE CUFF OF THE GLOVE RIPPED HALFWAY OFF ON THE RIGHT SIDE. THERE WAS NOT VERY MUCH PRESSURE USED IN PUTTING THE GLOVE ON, MUCH LESS THAN NORMAL AS THIS HAS HAPPENED WITH THIS TYPE OF GLOVE IN THE PAST. (GLOVE REF: (B)(4), LOT: TS20100210, MFG: 2020-10-17 USE BY DATE: 2023-09-30). SECOND EVENT. WHEN RN OPENED A PAIR OF ORANGE PROTEXIS PI STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES (SIZE 6 1/2, (B)(4), LOT# TS20100108, USE BY DATE 2023-09-30), THEY RIPPED APART AS RN WAS PUTTING THEM ON. WE HAVE HAD SEVERAL OF THESE [PROTEXIS PI SURGICAL GLOVES] DOING THIS.
Patient problems: Insufficient Information
MAUDE report 11723549 ↗
Other Surgeon's gloves devices
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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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