LYZ
- 产品代码
- LYZ
- 器械名称
- Vinyl Patient Examination Glove
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 880.6250
- FDA 专业组
- General Hospital
- 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)
- 4 件
- 其中 Summary 已存档
- 3 份,可直接下载
- FDA 历史累计 510(k)
- 799 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
该代码近三年的 510(k)(4 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260860 | 2026-04-07 | Basic Medical Technology, Inc. | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black… | |
| K252467 | 2025-10-27 | Viet Phu Trade and Import Export Co., … | Disposable Vinyl Examination Gloves | — |
| K252505 | 2025-08-28 | Basic Medical Technology, Inc. | Powder-Free Vinyl Exam Gloves, clear | |
| K241252 | 2024-05-20 | Anqing Pukang Medical Technology Co., … | Disposable Vinyl Examination Gloves |
FDA 官方分类页: LYZ
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。