QDO
- 产品代码
- QDO
- 器械名称
- Fentanyl And Other Opioid Protection 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
FDA 分类定义
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
FDA 官方分类页： QDO
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。