Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) → QDO — Fentanyl And Other Opioid  Protection Glove

# QDO · Fentanyl And Other Opioid  Protection Glove

_General Hospital · 21 CFR 880.6250 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QDO

## Overview

- **Product Code:** QDO
- **Device Name:** Fentanyl And Other Opioid  Protection Glove
- **Regulation:** [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

## Classification Rationale

Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QDO](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QDO)

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