Importation of Masks, Hand Sanitizer, and Medical Gowns

Food and Drug Administration (FDA)

March 24, 2020 – Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, there has been an increase in the importation of protective masks, hand sanitizer, and medical gowns to avoid exposure. Livingston has researched these products to determine if this merchandise would be regulated by the FDA, and if so, what would be required.

The World Customs Organization (WCO) has also provided trade with an HS Classification Reference for COVID-19 Medical Supplies that can be referenced for any tariff classifications related to high demand medical supplies.

U.S Customs and Border Protection services has published a notice, CSMS #42124872 on information for filing personal protective equipment and medical devices during COVID-19.

Masks

  1. Products such as masks/respirators to protect against pathogens or prevent exposure to disease, surgical masks or N95 respirators intended to reduce exposure to pathogens or any product intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals is considered a medical device regulated by FDA.
    • If it is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids – it is therefore regulated as a medical device by FDA.
    • The following information must be reported to FDA for products categorized as medical devices:
      • FDA Actual Manufacturer
      • Device Foreign Exporter Registration Number (DFE)
      • Device Premarket Notification number (510K)
      • Device Listing Number for product (LST)
      • Device Foreign Manufacturer Registration Number (DEV)
  2. General Purpose Masks (e.g. hygiene, at-home cleaning masks, for use in a nail salon, for use in food service, etc.) and/or Filtering Facepiece Respirators (FFRs) intended for industrial use (e.g. N95 respirators for preventing fumes, dust, etc.) only; in other words, those NOT for use in healthcare settings and not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, are not typically regulated by FDA.

Hand Sanitizer

Hand Sanitizer is always considered a drug by FDA standards if it contains an active ingredient. Typically hand sanitizer contains alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride – which are all considered to be active ingredients.

  1. The following information must be reported to FDA for products categorized as drugs:
    • FDA Actual Manufacturer
    • Drug Listing Number (Formerly NDC Number)
    • Drug Registration Number (DUNS Number)

Medical Gowns

Medical Gowns that are going to a hospital or medical facility would be regulated by FDA as a medical device. There are several different types of gowns and can vary from within how they are regulated. Medical gowns are typically divided into two classes, Class I and Class II. These classes are determined by the FDA product code. The importer must know what FDA product code the product is registered with FDA under.

  1. The following information must be reported to FDA for Class I medical devices:
    • FDA Actual Manufacturer
    • Device Foreign Exporter Registration Number (DFE)
    • Device Listing Number for product (LST)
    • Device Foreign Manufacturer Registration Number (DEV)
  1. The following information must be reported to FDA for Class II medical devices:
    • FDA Actual Manufacturer
    • Device Foreign Exporter Registration Number (DFE)
    • Device Premarket Notification number (510K)
    • Device Listing Number for product (LST)
    • Device Foreign Manufacturer Registration Number (DEV)