Exim Trade

Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. They are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC).

However, some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.

N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:

• The respirator is intended to prevent specific diseases or infections,
• The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity,
• The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

N95 respirators and other professional-grade medical masks are carefully sized to form a tight seal between the air outside and the face. They are designed to protect healthcare workers from droplets in the air.

Respirators are highly effective when professionally fitted. Healthcare workers who wear N95 masks undergo a detailed test of the mask’s fit to ensure that it creates a full seal – a service currently unavailable to the general public.

Some reports have found that online sellers of “professional-grade masks” are actually selling ineffective counterfeits. N95s are currently considered an essential but scarce supply for healthcare workers. Avoid wearing these masks to conserve PPE.