ORW · N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
General Hospital · 21 CFR 880.6260 · Class 2
Overview
| Product Code | ORW |
|---|---|
| Device Name | N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies |
| Regulation | 21 CFR 880.6260 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093189 | ACTIPROTECT UC N95 RESPIRATOR | Glaxosmithkline Consumer Healthcare | Jul 2, 2010 | SESE |
Top Applicants
- Glaxosmithkline Consumer Healthcare — 1 clearance
