U.S. Customs and Border Protection reports that effective May 19 exports of the following no longer are no longer restricted by the Federal Emergency Management Agency.
- industrial N95 respirators, including devices that are currently NIOSH-approved for use in healthcare settings under an emergency use authorization issued by the Food and Drug Administration
- PPE surgical masks, as described by 21 CFR 878.4040, including masks that cover the user’s nose and mouth providing a physical barrier to fluids and particular materials, that meet fluid barrier protection standards pursuant to ASTM F 1862 and Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards
- piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860 that are compliant with ISO 7886-1:2017 and use only current good manufacturing practices processes
- hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act
FEMA export restrictions remain unchanged for (1) surgical N95 respirators; i.e., single-use, disposable respiratory protective devices used in a healthcare setting that are worn by healthcare personnel 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, (2) PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes, and (3) level 3 and 4 surgical gowns and surgical isolation gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by surgical gown barrier performance based on AAMI PB70.
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