---
kind: "section"
citation: "21 C.F.R. § 880.6260"
title: "21"
number: "880.6260"
heading: "Filtering facepiece respirator for use by the general public in public health medical emergencies."
url: "https://uscodex.org/cfr/21/880.6260"
---

# §880.6260. Filtering facepiece respirator for use by the general public in public health medical emergencies.

- (a) **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.
- (b) **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](/cfr/42/part84.md).
  - (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)](/cfr/21/880.1.md?p=e) for information on obtaining a copy of this guidance document.

## Notes

### Amendments

[72 FR 36362, July 3, 2007]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[72 FR 36362, July 3, 2007]