Certified Respirators

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and provide a minimum of 95% efficient filtration of airborne particles.  The edges of the respirator are designed to form a seal around the nose and mouth. 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).

A face mask is a product that covers the wearer’s nose and mouth. These are unregulated and available to the general public in a wide variety of materials and shapes. These are not personal protective equipment. Face masks may or may not meet any fluid barrier or filtration efficiency levels; therefore, they are not a substitute for N95 respirators or other Filtering Facepiece Respirators (FFRs).

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as surgical masks. The edges of the mask are not designed to form a seal around the nose and mouth. The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use. While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.

Surgical N95 Respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices used and worn by healthcare personnel during procedures to protect both the patient and healthcare 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.

The National Institute for Occupational Safety and Health (NIOSH) is a research agency for the Centers for Disease Control (CDC) dedicated to worker safety and health. N95 respirators are awarded NIOSH approval when they have been evaluated in a laboratory and found compliant with the requirements laid on in Title 42, Code of Federal Regulations, Part 84. The manufacturer must also submit a quality plan that must be approved. 

When using N95 respirators in a professional setting, you should always use N95 respirators that are NIOSH approved.

P2 is a respiratory filter rating under the AS/NZS1716 standards for use in Australia and New Zealand. It protects against mechanically and thermally generated particles. The P2 rating filters at least 94% of airborne particles. Suitable for relatively small particles generated by mechanical processes eg. grinding, cutting, sanding, drilling, sawing. Sub-micron thermally generated particles e.g. welding fumes, fertilizer and bushfire smoke.

FFP2 is a term used in the European Union and stands for filtering face piece (FFP) mask or filtering half mask. The 2 indicates a filtering capacity of a minimum of 94%.  Requirements for FFP’s are controlled in the personal protective equipment Regulation (EU) 2016/425 category III. The EN 149 standard defines performance criteria for the classes of particle-filtering half masks. These masks are considered to be similar to N95 and P2 respirators.