§ 880.6260. Filtering facepiece respirator for use by the general public in public health medical emergencies.
177 words·~1 min read·
/us/cfr/t21/s§ 880.6260·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
Connections5 cite this
Cited by 5 sections · top 3
1 reference not yet in our index
- 42 CFR 84
Citation graph
cites case law
§ 880.6260
Filtering facepiece respirator for use by the general public in public health medical emergencies.
Fed. Reg.×5
Cite42 CFR 84
Cites 1Cited by 5 across 1 source