Home › Device types › KGO
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
Biogel — Bosma EnterprisesMedicom AssureTouch — AMD Medicom IncCriterion CR Surgeons Glove — HENRY SCHEIN, INC.Dexters — Guilin HBM Health Protections, Inc.Prestige® Micro — INNOVATIVE HEALTHCARE CORPORATIONGAMMEX — Ansell Healthcare ProductMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Biogel® PI Micro Indicator® System — Mölnlycke Health Care ABGammex — Bosma EnterprisesBiogel — Bosma EnterprisesMocareHealth — Motex Healthcare(Anhui)Co.,Ltd.MocareHealth — Motex Healthcare(Anhui)Co.,Ltd.NATURAL EXTENSIONS — BENCO DENTAL SUPPLY CO.MEDLINE — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Biogel® M — Mölnlycke Health Care ABCORRECT TOUCH — Ct InternationalCORRECT TOUCH — Ct InternationalGammex — Bosma EnterprisesDealmed — DEALMED MEDICAL SUPPLIES LLCPremierPro Surgeons Glove — PRESTIGE AMERITECH, LTD.Encore — Bosma EnterprisesSnow Lotus — Beijing Reagent Latex Products Factory
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i |
| 2023-08-03 | Ansell Healthcare Products LLC | Some surgical glove sterile pouches were not completely sealed. |
| 2023-08-03 | Ansell Healthcare Products LLC | Some surgical glove sterile pouches were not completely sealed. |
| 2022-03-15 | Cardinal Health 200, LLC | Product was distributed without being sterilized. |
| 2022-02-19 | Ansell Healthcare Products LLC | Transport company failed to stop at the border for required FDA inspection. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
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