Importing Personal Protective Equipment (PPE), KN95, or N95 masks

20May

Importing Personal Protective Equipment (PPE), KN95, or N95 masks

Are you importing or planning to import Personal Protective Equipment (PPE)? PPE, once a low-value item, is now the fastest growing commodity by volume and by value in Europe and North America.

Did you know that James J Boyle & Co has more than 40 years of experience handling Customs and FDA clearances of food and medical products? At James J Boyle & Co we have your back when it comes to international freight forwarding and U.S. import clearance of PPE! Please contact us for more information and find out why our customers are so satisfied with our service!

Los Angeles office: Bing Wang (Mandarin Speaking) bwang@wordpress-226604-2678892.cloudwaysapps.com & Henry Lee (hlee@wordpress-226604-2678892.cloudwaysapps.com)
Portland office: Lisa Whiles (lwhiles@wordpress-226604-2678892.cloudwaysapps.com)
Seattle office: Kiera Mann (kmann@wordpress-226604-2678892.cloudwaysapps.com)

Tips on Importing Face Masks or other PPE as Trouble-Free as Possible

Whether masks are considered medical devices or not, is based on intended use, regardless of how it is sold.
Labeling is a key characteristic when determining if FDA clearance is required.
Labeling of Non-Surgical Face Masks that do not require FDA entry:
- Masks must be labeled accurately to describe the product as a face mask and include a list of the body-contacting materials (cannot include any drugs or biologics).
- Masks intended for personal, non-medical use, must NOT be labeled or marketed as “surgical masks” or that it provides liquid barrier protection.
- The labeling must include recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high.
- Labeling cannot state or imply that the product is intended for antimicrobial or antiviral protection or for use in infection prevention.
- The product cannot be labeled as a respiratory protective device or for use for particulate filtration or labeled for use in high risk aerosol generating procedures.
Non-FDA-regulated PPE such as face masks that are for General Purpose or Industrial Use do not require FDA entry and may be disclaimed.
Surgical (medical) Masks: Depending on device classification, premarket notification may be required.
FDA Registration: All manufacturers of medical devices must register with the FDA. See Device Advice and How to Study and Market Your Device links.
EUA: To battle the COVID outbreak, FDA has authorized an Emergency Use Authorization for certain PPE. For information related to this authorization please review the NIOSH-Approved Disposable Filtering Facepiece Respirators for Use in Healthcare Settings During Response to the COVID-19 Public Health Emergency.
N95 masks: FDA guidance states that such masks may be imported with lower restrictions if going to medical professional organizations, and can be disclaimed if the masks are for non-medical uses.
KN95 masks (the Chinese equivalent of N95 masks): can also be brought in with lowered restrictions but FDA is still very strict about the types of masks eligible for these modified requirements.
Hand Sanitizers are over-the-counter drugs regulated by FDA, are listed on the National Drug Code (NDC) Directory, and must include a “Drug Facts” label.

Medical PPE Checklist

If the PPE items you intend to import ARE intended for medical use, FDA must be claimed and the following information is generally required:

Device Listing Number
Manufacturer Registration Number
Exporter Registration Number
510(k) Premarket Number

Emergency Use Authorization (EUA) Approved PPE

If the item is listed as “approved for EUA, the above information becomes optional by using an “Intended Use Code”.
Providing the information to FDA at time of entry is still encouraged if the importer has it.
See list of specific EAU-approved models of diagnostic tests and masks/respirators, which include National Institute for Occupational Safety and Health (NIOSH)-approved and non-approved masks.

Non-EUA Items

Items not listed as approved for EUA can still be imported with reduced restrictions using a different intended use code.
The intended use code flags the item as being subject to reduced restrictions due to a published enforcement discretion policy. The FDA checklist information above is also waived for this category.
This category includes items such as non-invasive remote monitoring devices, ventilators, and other accessories/respiratory devices.
Although the U.S. reduced enforcement, China has increased enforcement. Therefore it is important that your shipper confirm in advance that it has all necessary approvals and licenses from the Chinese government even if the U.S. does not need this information at time of entry.

ACE Entry Requirements for Non-EUA KN95, KN100, KP100 and KP95

Program Code: DEV
Processing Code: NED
Intended Use Code: 940.000 if the product is listed on the CDC website
Intended Use Code: 081.001 if not listed on the CDC website
Product Code: 80N-ZJ

Also see Customs & Border Protection’s Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 and CBP’s PPE Importing Guidance page.

For additional detailed information concerning various U.S. government agencies’ updates related to COVID-19, we have gathered and provided their webpage links, which are grouped by government agency sections.

If you have any questions, please do not hesitate to contact the experts at JJB!

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