FDA Device Intelligence
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Surgeon'S Gloves

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

2,513
Registered devices
1,047
Adverse events
44
Recalls
560
510(k) clearances

Devices with this code

Protexis — Bosma EnterprisesMocareHealth — Motex Healthcare(Anhui)Co.,Ltd.MocareHealth — Shanghai Motex Healthcare Co.,Ltd.ENCORE — Ansell Healthcare ProductNOVAPLUS — Ansell Healthcare ProductSempermed Supreme Latex Surgical Glove — Harps USA, Inc.Biogel Sensor® — Mölnlycke Health Care ABBiogel® PI Micro — Mölnlycke Health Care ABGAMMEX — Ansell Healthcare ProductBiogel PI Pro-Fit® — Mölnlycke Health Care ABPROTEXIS — Cardinal Health 200, LLCHenry Schein — HENRY SCHEIN, INC.MEDLINE — MEDLINE INDUSTRIES, INC.MocareHealth — Motex Healthcare(Anhui)Co.,Ltd.Biogel — Bosma EnterprisesGammex — Bosma EnterprisesBiogel® Indicator® System — Mölnlycke Health Care ABMocareHealth — Motex Healthcare(Anhui)Co.,Ltd.McKesson — MCKESSON MEDICAL-SURGICAL INC.PROTEXIS — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Gammex — Bosma EnterprisesMocareHealth — Motex Healthcare(Anhui)Co.,Ltd.MEDLINE — MEDLINE INDUSTRIES, INC.

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.