LZC
- 产品代码
- LZC
- 器械名称
- Medical Glove, Specialty
- 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)
- 79 件
FDA 分类定义
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
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 |
|---|---|---|---|
| K252313 | 2026-01-14 | Cardinalhealth | Cardinal Health Nitrile Examination Gloves Extended |
| K243959 | 2025-02-24 | Lingshi Hongruida Health Protection Te | Powder Free Nitrile Examination Gloves (Violet, Blac 摘要 |
FDA 官方分类页: LZC
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。