PROTEXIS 2D72PL70XRecalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380031779), received between Sep 28, 2018 and Aug 25, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
Patient problems
- Anaphylactic Shock1
- Hypersensitivity/Allergic reaction1
- Local Reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING PLACEMENT OF AN IMPLANTABLE CATHETER FOR CHEMOTHERAPY, IT WAS REPORTED THAT FROM THE CLINICIAN¿S STERILE NITRILE GLOVES, THE PATIENT DEVELOPED A SENSATION OF GENERALIZED PRURITUS, GENERALIZED RASH WITH APPEARANCE OF HIVES, FEELING OF DYSPNEA, DIZZINESS WITH TENDENCY TO WORSEN. PATIENT WAS SENT TO THE EMERGENCY ROOM FOR MONITORING OF CONDITION AND ANAPHYLAXIS. PATIENT REQUIRED 02 THERAPY TO RAISE SATURATION FROM 85-87% TO 94%. 40MG OF DEFIDRAMINE IV AND 100MG OF HYDROCORTISONE WERE ADMINISTERED TO THE PATIENT. THE PATIENT WAS REPORTED AS STABLE AFTER TREATMENT.
Patient problems: Anaphylactic Shock
MAUDE report 15299257 ↗InjurySep 28, 2018Biocompatibility
XRAY TECH HAD INITIALLY CALLED REGARDING OBTAINING GLOVE INGREDIENTS IF NEEDED. SHE WAS GETTING BLISTERS ON HER HANDS FOR THE PAST 2 MONTHS, BUT WAS NOT SURE WHAT WAS CAUSING HER SYMPTOMS. SHE HAD BEEN USING THE GLOVES FOR ABOUT A YEAR BUT HER SYMPTOMS WERE RECENT. SHE HAD SEEN A PA TWICE AND A DERMATOLOGIST ¿ THEY WERE GOING THROUGH THE PRODUCTS SHE USES TO TRY AND IDENTIFY THE CAUSE. ON (B)(6) 2018 SHE CALLED STATING HER PATCH TESTING SHOWED SHE WAS ALLERGIC TO CARBA MIX. HER HANDS ARE DOING BETTER.
Patient problems: Hypersensitivity/Allergic reaction; Local Reaction
MAUDE report 7917990 ↗
Other Surgeon's gloves devices
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- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- 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
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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