Fentanyl And Other Opioid Protection Glove
Device Code: 2792
Product Code(s):
QDO 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 Chemothera
Device Classification Information
| Device Type ID | 2792 |
| Device Name | Fentanyl And Other Opioid Protection Glove |
| Physical State | Polymer Examination Medical Glove |
| Technical Method | Device Is Worn On The Hand |
| Target Area | Skin Of The Hand |
| Regulation Description | Non-powdered Patient Examination Glove. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QDO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2792 |
| Device | Fentanyl And Other Opioid Protection Glove |
| Product Code | QDO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |
TPLC Last Update: 2019-04-02 20:18:52