LYY
- 产品代码
- LYY
- 器械名称
- Latex 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)
- 1954 件
FDA 分类定义
A latex patient examination glove is a disposable device made of natural rubber latex 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)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K250069 | 2025-04-29 | Comfort Rubber Gloves Industries Sdn. | Powder Free Natural Rubber Latex Examination Gloves 摘要 |
| K240266 | 2024-09-09 | Sri Trang Gloves (Thailand) Public Com | Latex Examination Glove Powder Free (Ocean Blue and |
FDA 官方分类页: LYY
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。