FDA issues enforcement policies to notify the public of its intent to not enforce certain regulatory requirements that would otherwise apply. FDA issued a number of enforcement policies during the pandemic. For example, FDA issued an enforcement policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel during the COVID-19 public health emergency. This policy remains in effect for the duration of the COVID-19 public health emergency:
We are marketing the following masks under the enforcement policy:
Flat Surgical Face Mask Model# FE2311 Level II
Flat Surgical Face Mask Model# FE2311X Level III
Flat Face Mask Model# Costco Face Mask
Flat Face Mask Model# FE2211-Face Mask
Flat Face Mask Model# FE2411 BLUE
Flat Face Mask Model# FE2411 PINK
Flat Face Mask Model# FLAT Single Use Face Mask
Flat Face Mask Model# FE2411 Option 1-Pattern
Flat Face Mask Model# FE2411 Option 2-Pattern
A face mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks may be used by the general public and health care personnel as source control, to cover the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals.
A surgical mask covers the user’s nose and mouth and provides a physical barrier to fluids and particulate material. Unlike a face mask, a surgical mask must meet certain fluid barrier protection standards and Class I or Class II flammability tests.
For more information, please see:
EN 14689 2019 standard table
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