FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Corona Virus Disease (COVID-19) pandemic. The FDA is committed to providing timely guidance to support response efforts to this pandemic.
COVID-19 is a respiratory illness caused by a novel coronavirus. This virus can be spread from person to person by respiratory droplets produced when an infected person coughs or sneezes, and by touching an object that is contaminated with the virus and then touching facial mucous membranes (mouth, nose, eyes).
During an infectious disease outbreak, health care workers are on the front lines and therefore at increased risk of being exposed to and contracting the disease. The Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) require health care workers caring for patients with suspected or confirmed infectious disease to wear respiratory protection. The COVID-19 Pandemic has led to an ongoing shortage of respiratory protection devices.
The FDA definitions of face masks, filter facepiece respirators and surgical respirators.
- Face Mask: A mask that covers the user’s nose and mouth : May or may not meet fluid barrier or filtration efficiency levels.
- Surgical Mask: A mask that covers the user’s nose and mouth : Provides a physical barrier to fluids and particulate materials. These masks meet certain fluid barrier protection standards and Class 1 or Class II flammability tests.
- Filtering facepiece respirator (FFR): a disposable half-facepiece nonpowered air-purifying particulate respirator: Intended for use to cover the nose and mouth and helps reduce wearer of exposure to pathogenic biological airborne particulates.
- N95 Respirator: A disposable half mask FFR: Covers the user’s nose and mouth: Offers protection from particulate materials at an N95 filtration efficiency level, per 42 CFS 84.181. An N95 FFR used in a health care setting is a class II device regulated by the FDA under 21 DFT 878.4040 (FDA product code MSH).
- NIOSH-approved N95 respirator: An N95 Respirator approved by the National Institute for Occupational Safety and Health that meets filtration efficiency level per 42 DFR 84.181.
- Surgical N95 Respirator: a disposable FFR used in a health care setting. Worn by health care providers during procedures to protect both the patient and the provider from the transfer of microorganisms, body fluids and particulate material at an N95 filtration efficiency level per 42 CFR 84.181. Surgical N95 Respirator is a class II device regulated by the FDA under 21 CFR 878.4040.
The CDC has outlined specific recommendations for personal protective equipment to include gowns, gloves and respirators for health care workers on the CDC Personal Protective Equipment Recommendations resource page.
The CDC and NIOSH recommend that consumers always verify that respirators are listed on the approved NIOSH list. For more information on Respiratory Awareness see the NIOSH publication.
For more than 30 years, Scientific Instrument Center has served businesses that use a wide variety of diagnostic and scientific equipment. As a leader in Scientific Equipment Repair and medical device calibration, SIC works with many corporations, universities, and hospitals providing the highest level of laboratory services.
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