# QKU · Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/productcode/QKU

## Overview

- **Product Code:** QKU
- **Device Name:** Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see:  https://www.fda.gov/media/136664/download).    *This excludes NIOSH-approved respirators that are under EUA  *This includes authorized KN95s from China under EUA  *This excludes KN95s imported under enforcement discretion that don’t have EUA  *This includes all authorized non-NIOSH-approved FFRs under EUA

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/productcode/QKU](https://fda.innolitics.com/productcode/QKU)

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