top of page

Guidance for Exporters with a Surplus of Medical Supplies and Equipment

  • Writer: clarkespositolaw
    clarkespositolaw
  • Jul 28, 2021
  • 2 min read


The Federal Emergency Management Agency (FEMA) has updated the list of restricted items as of May 19, 2021.


Effective immediately, the following are no longer restricted from export under the FEMA’s Temporary Final Rule (TFR):

  • Industrial N95 Respirators, including devices that are currently NIOSH approved for use in healthcare settings under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA)

  • Personal Protective Equipment (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 (CGMP) processes; or

  • Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).

The review and restriction from export under FEMA’s TFR remains unchanged for these items:

  • Surgical N95 Respirators, that are 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 per 42 CFR 84.181.

  • 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.

  • 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

Have questions related to anything you've read above? Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at contact@clarkespositolaw.com.

Comments


How can we be of help?

New York Office:

211 E. 43rd Street, 7th Floor

New York, NY 10017

Connecticut Office:

9 Mott Ave., Suite 210

Norwalk,  CT 06850

917.546.6997

Stay Connected. Subscribe.

Thanks for subscribing!

  • YouTube
  • Instagram
  • LinkedIn
  • Facebook

Per The NY State Attorney Ethics Rules, See The Following Statement:

 

Attorney Advertising Disclaimer: The content of this website has been prepared by the Clark-Esposito Law Firm, P.C. for informational purposes only and should not be construed as legal advice. The material posted on this website is not intended to create, and receipt of it does not constitute, a lawyer-client relationship, and readers should not act upon it without seeking professional legal counsel. The Clark-Esposito Law Firm, P.C., did not produce and is not responsible for the content of off-site legal resources. The materials on this site may constitute advertising under various state ethics rules.

NYC, NYS, & PANYNJ M/WBE Certified Minority/Women Owned and Led Business

© 2025 by Clark-Esposito Law Firm, P.C.

bottom of page