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ENCORE

Ansell Healthcare Product · Model 5788004 · UDI-DI 00884792308847

KGOLZC
10
510(k) clearances
770
Adverse events (2 deaths)
44
Recalls
133
Facilities

Description

ENCORE® Latex Ortho Size 7.5, Sterile Latex Powder-Free Surgical Glove

Recalls

DateFirmReason
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2023-08-03Ansell Healthcare Products LLCSome surgical glove sterile pouches were not completely sealed.
2023-08-03Ansell Healthcare Products LLCSome surgical glove sterile pouches were not completely sealed.
2022-03-15Cardinal Health 200, LLCProduct was distributed without being sterilized.
2022-02-19Ansell Healthcare Products LLCTransport company failed to stop at the border for required FDA inspection.
2020-07-29Cardinal Health 200, LLCA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
2020-07-29Cardinal Health 200, LLCA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
2020-07-29Cardinal Health 200, LLCA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
2020-07-29Cardinal Health 200, LLCA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
2020-07-29Cardinal Health 200, LLCA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.