FDA product code QDO: Fentanyl And Other Opioid Protection Glove
QDO is the FDA product code for fentanyl and other opioid protection glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. Devices under QDO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Fentanyl And Other Opioid Protection Glove |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QDO devices
openFDA lists no recalls for product code QDO.
Frequently asked questions
What is FDA product code QDO?
QDO is the FDA product code for fentanyl and other opioid protection glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is QDO?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QDO
- Run a recall and safety report across every QDO manufacturer
- Watch product code QDO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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