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)
- 799 件
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 |
|---|---|---|---|
| K260860 | 2026-04-07 | Basic Medical Technology, Inc. | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black 摘要 |
| 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 摘要 |
| K241252 | 2024-05-20 | Anqing Pukang Medical Technology Co., | Disposable Vinyl Examination Gloves 摘要 |
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。