The Federal Emergency Management Agency (FEMA) has filed a temporary final rule to amend export restrictions on certain types of personal protective equipment products (“PPE materials”) used in the response to the COVID-19 pandemic.
While this rule remains in effect, Shippers are unable to export any such designated materials from the United States without explicit approval by FEMA.
The rule covers five types of personal protective equipment (PPE):
- Surgical N-95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
- PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials;
- PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and other such nitrile gloves intended for the same purposes.
- Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all the requirements in ANSI/AAMI PB70 and ASTM F2407 – 06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70. at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.
- Specific syringes and hypodermic needles (whether distributed separately or attached together). The designated materials are piston syringes and hypodermic needles that are either: 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 Practice (CGMP) processes; or hypodermic single lumen needles as described by 21 CFR 880.5570 that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act.
We invite you to review the temporary final rule, which is available on the Federal Register. Should you have questions or concerns, please contact us, or if you are already working with us, direct them to Your Sales Account Manager.