Importing Personal Protective Equipment (PPE)

Key details U.S. importers need to know about importing non-medical general-purpose personal protective equipment (PPE), medical use PPE or medical devices.

Overview for Importers

The information below is subject to change as the current COVID-19 pandemic evolves. Personal Protective Equipment (PPE) and medical devices are broken up into different classes depending on their function and complexity, the intended use and indications for use. Current regulations provide for relaxed requirements on some products imported under Emergency Use Authorization (EUA).

PPE Classes

Non-Medical Use General Purpose PPE – Not FDA Required
Medical Use PPE Authorized by EUA (Emergency Use Authorization) – FDA required with new Intended Use Code
Medical Use PPE Not Authorized by EUA – Requires All Standard FDA Data Elements to be Reported

Non-Medical Use PPE

General Purpose Personal Protective Equipment (PPE) is not intended to be used in the medical community and is not intended for use to prevent disease or illness. These items do NOT require any FDA information to be transmitted and should use a Harmonized Tariff code that does NOT flag for FDA or flags FD1 and is disclaimed.

Product Descriptions

Paint or dust masks or respirators purchased at a hardware store.
Food-service gloves or Playtex gloves for use in households for cleaning, household tasks.

Importing Guidelines for Non-Medical PPE

General purpose masks, respirators and gloves.

Non-medical PPE products are intended for non-medical use (for example, general purpose or industrial use) and are not intended for use to prevent disease or illness. As an example, paint or dust masks or respirators that could be purchased at a hardware store. They are not a medical device nor intended to be used as one, nor are they classified as medical devices by the FDA.

Non-medical PPE products do not require entry information to be transmitted to the FDA. A correct Harmonized Tariff Schedule of the United States (HTSUS) tariff code should be utilized that either has no FDA flag or an FD1 flag. In the case of the latter, a disclaim should be submitted for FDA.

Non-medical PPE items would NOT be used in a medical setting – medical facility.

Medical Use PPE and Medical Devices

About Medical Use PPE

Medical Use PPE and Medical Devices are used in the public health arena and are regulated by the Food and Drug Administration (FDA).

Depending on the item, FDA Product Codes are required, and Intended Use Codes must be transmitted. Some items will require reduced FDA information if the item falls under the Enforcement Discretion policy.

Certain FDA-regulated medical devices fall outside the scope of Emergency Use Authorization or Enforcement Discretion Policy and require all standard FDA data elements to be reports (LST #, DEV #, DFE #) as well as an appropriate FDA Intended Use Code.

PPE Authorized by Emergency Use Authorization

Product Descriptions

Personal Protective Equipment imported under the Emergency Use Authorization to allow expedited importation of certain products that address immediate, urgent health needs.

FDA information is still required for review.

Compassionate Use/Emergency Use Device - Intended Use Code 940.000

List of products and product codes authorized for EUA:

Diagnostic tests: 83QPK, 83QKO, 83QJR, 83OTG

N95 style Respirator Masks for use by General Public: 80NZJ

Reduced FDA information is required for review if a device falls under EUA – the reporting of Affirmation of Compliance codes such as the registration, premarket numbers and the listing number is not required.

CSMS #42168200

Importing Guidelines for PPE Authorized by EUA

FDA Regulated Medical Devices and PPE authorized for emergency use pursuant to an Emergency Use Authorization (EUA):

These products are medical devices and PPE that require FDA entry submission. The specified products should have Intended Use Code 940.000: Compassionate Use / Emergency Use and an appropriate FDA product code applied to speed up FDA review and release. Reduced FDA information is required for review if a device falls under EUA – the reporting of Affirmation of Compliance codes such as the registration, premarket numbers and the listing number is not required.

Three FDA product codes for diagnostic tests (83QPK, 83QKO, 83QJR) and one FDA product code for a mask/respirator (80--NZJ) are covered under EUA per CSMS # 42168200. Other types of masks would fall under the “all other FDA-regulated products section” listed below. Product code 80--NZJ covers N95 style respirator masks for use by the general public. Specifics on N95 style masks can be found on the FDA’s website. More information on EUA can be found on the FDA EUA page.

Guidance documents from FDA on products related to COVID-19 can be found at the links below:
A complete list of FDA guidance documents related to COVID-19 is also available. For more information, please contact your local Ascent Global Logistics representative.
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