21 CFR § 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies.
---
identifier: "/us/cfr/t21/s880.6260"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6260"
section_name: "Filtering facepiece respirator for use by the general public in public health medical emergencies."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---
# 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.
(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.
[72 FR 36362, July 3, 2007]