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Nulife

MRK HEALTHCARE PRIVATE LIMITED · Model Elbow length Gynaecology gloves - 7.5 · UDI-DI 08905159002139

KGO
1
510(k) clearances
770
Adverse events (2 deaths)
44
Recalls
133
Facilities

Description

Elbow Length gynaecology gloves are sterile, anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat with length till elbow. These gloves are powder-free. The Elbow length gynaecology gloves are intended for use various gynecological procedures.

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.