FDA Device Intelligence
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Surgeon'S Gloves

FDA product code KGO · Class 1 · General, Plastic Surgery

2,497
Registered devices
770
Adverse events
44
Recalls
560
510(k) clearances

Devices with this code

Recent 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 i
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.