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 880.6260](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6260) → NZJ — Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

# NZJ · Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

_General Hospital · 21 CFR 880.6260 · Class 2_

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

## Overview

- **Product Code:** NZJ
- **Device Name:** Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- **Regulation:** [21 CFR 880.6260](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6260)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.

## Classification Rationale

Class II (special controls). The special controls are:

## Special Controls

*Classification.* Class II (special controls). The special controls are:(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K083176](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NZJ/K083176.md) | PASTURE, MODELS: F550, A520 | Pasture Pharma Pte, Ltd. | Jan 23, 2009 | SESE |
| [DEN060009](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NZJ/DEN060009.md) | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | 3M Company | May 8, 2007 | DENG |

## Top Applicants

- 3M Company — 1 clearance
- Pasture Pharma Pte, Ltd. — 1 clearance

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

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