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PROTEXIS 2D73EB80Recalls & reported problems

Cardinal Health 200, LLC · Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating · Class 1

All models of PROTEXIS (17)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10885380027413), received between Sep 19, 2017 and Sep 20, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Operates Differently Than Expected1

Patient problems

  • Erythema2
  • Itching Sensation2
  • Reaction1
  • Skin Irritation1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem

    SCRUB TECHNICIAN DEVELOPED ITCHING, ERYTHEMA, SKIN DRYNESS WITH BREAKS IN FINGER JOINTS. THEIR SYMPTOMS STARTED APPROXIMATELY THE END OF (B)(6). THEY WORE THE GLOVES 8-10 MONTHS PRIOR TO HAVING A REACTION. THE EMPLOYEE HEALTH NURSE REFERRED THE TECHNICIAN OUT FOR EVALUATION. THEY WERE UNABLE TO SCRUB FOR 4 WEEKS AND CURRENTLY ARE PENDING RETURN TO FULL DUTY. THEY DISCONTINUED USING THE GLOVES.

    Patient problems: Erythema; Itching Sensation; Reaction; Skin Irritation

    MAUDE report 6878682 ↗
  • InjurySep 19, 2017Device Operates Differently Than Expected

    SCRUB TECHNICIAN DEVELOPED HAND ITCHING, REDNESS, BLISTERS AND ULCERS. THEIR SYMPTOMS STARTED IN FEBRUARY. THEY WORE THE GLOVES FOR APPROXIMATELY 1 YEAR BEFORE DEVELOPING SYMPTOMS. STEROIDS WERE FOLLOWED BY SEEING A DERMATOLOGIST AND TESTING FOR ALLERGIES. BACK TO WORK 6 WEEKS LATER. DISCONTINUED USING THE GLOVES.

    Patient problems: Erythema; Itching Sensation

    MAUDE report 6876660 ↗

Other Surgeon's gloves devices

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Sources and updates

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