Laufer Group International Bulletin: PPE and FDA Imports by Commodity

To Our Valued Customers:

 

Personal Protective Equipment (PPE) imports are very detailed and can be quite complicated. It is important for US companies to attend to every detail of the supply chain process before considering purchasing these goods from overseas.

Laufer’s consulting and compliance group has the expertise and experience to ensure smooth customs transactions for on-time product delivery.
We helped many customers navigate importing PPE who had no prior experience with these commodities. Because of these successes, many of these US importers now maintain these specialty items as part of their regular product lines.

This bulletin outlines some requirements for our top 3 PPE commodities:

 

Masks

We found several instances where our customers were provided with fake or erroneous documentation, which would have resulted in cargo detentions or entry rejections upon import

Classifications
• Surgical - with or without antimicrobial or antiviral agents
• Medical
• Non-Medical
• Respirator

FDA Considerations
• Review of packaging and marketing materials to determine end-use, which drives HTS classification and FDA requirements
• Non-medical masks do not have FDA filing requirements
• Surgical and medical masks require special FDA registration processes and reporting from the origin

 

Gloves

We have seen examples of containers being detained upon import. FDA sampling determined the products to be bad quality and/or mislabeled, which then required the product to be destroyed

Classifications
• Medical
• Non-Medical
• HTS considerations by material and construction
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FDA Considerations
• Review of packaging and marketing materials to determine end-use, which drives HTS classification and FDA requirements
• Most all gloves are required to have an FDA filing upon importation
• If ‘surgical grade’ is listed on the outer box, FDA requirements will apply regardless of end use/user
• Ensuring the manufacturer/supplier is registered with the FDA and identifying the medical device listing number through dedicated research is crucial

 

Hand Sanitizer

FDA detained shipments of hand sanitizer which contained banned ingredients as PPE importers spiked in 2020 and these commodities became an increased area of concern

Classifications
• Gel/Liquid
• Wipes
• HTS considerations by active ingredient and percentage

FDA Considerations
• Hand sanitizers are considered an over the counter drug, as they claim to alter the physical make of the human body with the removal of bacteria and viruses
• FDA registration and reporting is required. The origin party can register and the US importer can be on their exports listing
• Ensuring the manufacturer/supplier is registered with the FDA and identifying the medical device listing number through dedicated research is crucial

 

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