KGO
- 产品代码
- KGO
- 器械名称
- Surgeon'S Gloves
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 878.4460
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 9 件
- 其中 Summary 已存档
- 6 份,可直接下载
- FDA 历史累计 510(k)
- 560 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260558 | 2026-07-28 | Hartalega NGC Sdn. Bhd. | Latex Powder Free Surgical Gloves Tested for Use wit… | |
| K253060 | 2026-05-22 | Protect Gloves Company Limited | Sterile Latex Powder Free Surgical Gloves | |
| K250313 | 2025-08-19 | Harps Europe Manufacturing GmbH | Sterile Powder Free Synthetic Rubber Surgeons Glove… | |
| K240790 | 2024-08-23 | Suzhou Colour-Way New Material Co., Lt… | Polyisoprene Surgical gloves | — |
| K232079 | 2024-03-28 | Wrp Asia Pacific Sdn. Bhd. | Natural Rubber Latex Surgical Glove, Powder Free, St… | |
| K232444 | 2023-12-20 | Grand Work Plastic Products Co., Ltd. | Sterile Powder Free Latex Surgical Gloves, Tested fo… | |
| K231902 | 2023-10-20 | Ansell Healthcare | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid… | FDA |
| K231973 | 2023-09-29 | Ineo Tech Sdn Bhd | PolyIsoprene Powder Free Black Colour Radiation Atte… | FDA |
| K231446 | 2023-09-22 | Fitone Latex Products Co., Ltd. Guangd… | Single-Use Latex Sterile Surgical Gloves (SG100) |
FDA 官方分类页: KGO
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。