Health Care Masks: Types, Definitions, Classifications and Approved Models

To assist our health care supply chain peers, AHRMM has researched and outlined the types of masks and respirators and their efficacies, CDC and FDA approved models, EUA guidance and definitions. Refer to the indicated websites for more information.

Mask Types, Efficacies and Approved Models

Approved Models: https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html

Appendix A:

Definitions

• Face Mask – A mask that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels.
• Surgical Mask – A mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests.
• Filtering Facepiece Respirator – A filtering facepiece respirator (FFR) is a device that is a disposable half-face-piece 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.
• N95 Respirator – A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181. Such an N95 FFR used in a healthcare setting is a class II device, regulated by FDA under 21 CFR 878.4040 (FDA product code MSH).
• NIOSH Approved N95 Respirator – An N95 respirator, approved by NIOSH that meets filtration efficiency level per 42 CFR 84.181.
• Surgical N95 Respirator – A disposable FFR used in a healthcare setting that is worn by HCP during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181. A surgical N95 respirator is a class II device, regulated by FDA under 21 CFR 878.4040 (FDA product code MSH).

Fit Testing Guidelines, Distributor Information, and Certified Equipment Information

Guidelines: Fit Testing. OSHA
Validate 3M Masks. 3M
Certified Equipment List Search: CDC

Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection

“For the duration of the public health emergency FDA does not intend to object to the distribution and use of face masks (not including respirators) that are intended for a medical purpose (whether used by medical personnel or the general public), without compliance with the following regulatory requirements where the face mask does not create an undue risk in light of the public health emergency:…”

“FDA recognizes that, when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.”

Surgical Masks Intended to Provide Liquid Barrier Protection

“FDA does not intend to object where, for the duration of the declared public health emergency, surgical masks are distributed and used without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81, and the surgical masks do not create an undue risk in light of the public health emergency. FDA currently believes such devices would not create an undue risk where:…”

FDA’s Intended Approach for EUAs for Masks and Respirators

“To facilitate the safe reuse and conservation of PPE for the duration of the public health emergency, FDA is interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators (and other Filtering Facepiece Respirators) to facilitate marketing authorization through an emergency use authorization (EUA) for reprocessed devices. FDA recommends that firms contact FDA and provide the following information to CDRH-COVID19-SurgicalMasks@fda.hhs.gov, if available. FDA will work with reprocessors through its EUA process to facilitate expedited evaluation of the request. To help facilitate the pre-EUA discussions, we recommend that you send FDA as much of the following information you have available:…”

FDA Enforcement Policy for Face Masks

Download the document.