OIG
- 产品代码
- OIG
- 器械名称
- Powder-Free Guayle Rubber 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)
- 1 件
FDA 分类定义
A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
FDA 官方分类页： OIG
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。