Consulting for Importing Face Masks

Posted by Ken Lim on

Customs consulting for importing N95 and K95 face masks can help you get these crucial products across the border during times of need.


Today’s climate has lots of crucial goods in short supply. Importing face masks is one way to get these essential products into the United States, but it doesn’t come without challenges. From dealing with tariffs to medical device regulations to navigating customs clearance and documentation, you need a dedicated partner to get your face masks across the border and into the hands of those who need them. 

Importing face masks is more important than ever. Face masks are essential pieces of personal protective equipment (PPE). In today’s global climate, the demand for face masks is surging. Medical professionals, people working in essential businesses, and everyday consumers need PPE to stay healthy.

Tariffs on Importing Face Masks and KN95 Respirators

Face masks and N95 respirators are indispensable products in today’s world. During a pandemic, these masks are used to protect people from virus particles. According to information from the U.S. Food and Drug Administration, surgical masks and products like N95 respirators are designed to provide a physical barrier to stop droplets, splashes and sprays containing germs from reaching the wearer’s mouth and nose. The protective devices are crucial for health care workers and immunocompromised individuals during pandemics.

Many face shields and respirators are imported to the U.S. from China. The administration of President Donald Trump changed the trade policies around importing goods from China in 2018. Tariffs on goods coming from China increased with the new rules and regulations. 

However, as of March 5, 2020, Chinese-made face masks became exempt from the usual tariff imposed on goods from China. India is also a major supplier of face masks and can be considered a source of this vital product.

Importing face masks is more important than ever, and thanks to the tariff exemption, easier than ever. The right import consulting partner can make getting your goods through customs and across the border a headache-free process.  We can help you determine N95 mask import duty and make sense of mask import regulations. Let us help you help your business and keep the supply chain strong.

FDA Rules on Imported Face Masks

FDA rules on imported face masks

Face masks are medical devices and are considered surgical and infection control devices. This means they fall into FDA Device Class 2 and are required to meet certain ASTM standards. They undergo a variety of test methods and must comply with fluid resistance and filtration efficiency rules. 

Recent changes in rules have loosened mask import regulations. In fact, any Chinese-approved face mask can be imported into the country. This includes KN95 face masks and more.

When you’re sure your face masks meet FDA standards, you can begin the import process. 

What Are K95 Face Masks?

There are a variety of protective face masks on the market today. N95 masks and respirators might be the most common, but K95 face masks are common, too. N95 and K95 face masks are technically referred to as “filtering facepiece respirators.” We might know them as face masks. Regardless of what you call them, they are essential pieces of PPE required to keep people safe from germs, bacteria, and viruses. 

K95 face masks are imported face masks. The KNK95 refers to the country of origin. When you are importing face masks, the country of origin is important. This will help determine tariffs, product safety, and other important considerations required when importing PPE like face masks.

You can easily import K95 face masks through Shaphargroup global supply chain.

N95 Face Masks vs KN95 Face Masks

There are a variety of protective face masks on the market today. N95 masks and respirators might be the most common, but K95 face masks are common, too.

What’s the difference between N95 and K95 face masks? In short, not much. Each mask’s code refers to its country of origin. Simply put, KN95 face masks refer to masks produced in China. KF95 refers to masks produced in Korea, while FFP2 masks come from Europe. 

N95, KN95, KF95 and FFP2 masks and respirators all meet the same standards. Each code of mask will block particles as small as 0.3 microns in size. The Centers for Disease Control and Prevention has indicated the KN95, KF95 and FFP2 masks are suitable replacements for N95 

Importing N95, KN95, KF95 and FP2 face masks is smart for the supply chain. Talking with our team of experts in Shaphargroup can help you make sense around importing rules and regulations for each code of mask.

You’ll find there are a few slight differences in performance when thinking about N95 vs K95 face masks. It is important to know the difference when importing face masks.

Most significantly, the filter performance varies ever so slightly. The filter performance refers to the concentration of aerosols and droplets that can pass through the mask. N95 face masks filter out about 95% of particles. Chinese KN95 and Korean KF95 face masks on the other hand, filter out about 94% of particles. For most uses, the difference between N95 and K95 face masks is negligible.

Rules and regulations around importing KN95 and KF95 face masks recently changed. As of April 3, 2020, the FDA issued an emergency authorization for the approval and use of KN95 face masks. This opened the gates for importing KN95 face masks to help address the PPE shortage in the U.S. When coupled with tariff exemptions, this means importing KN95 face masks is a wise move for U.S. supply chains.

Other Alternatives to N95 and K95 Face Masks

Though N95 and imported KN95 and KF95 face masks might be the most in-demand PPE on the market today, they aren’t the only masks they provide safety and protection.

According to the  CDC, there are a few other options that can be used for protection outside of a surgical setting. Any NIOSH (National Institute for Occupational Safety and Health) approved mask can be used for protection against viruses. Alternatives to N95 and K95 masks include:

  • N99
  • N100
  • P95
  • P100
  • R95
  • R99
  • R100


What Other Documents Do I Need?

A customs bond isn’t the only documentation that needs to accompany your imported face masks. You’ll also need:

  1. Bill of Lading: A Bill of Lading is a receipt or list of goods required which each shipment.
  2. Packing List: A packing list displays details of the shipment with information like size, dimensions, and weight.
  3. Commercial Invoice: The commercial invoice includes data like the purchase price, customs clearance number, detailed item descriptions and more.
  4. Arrival Notice: An arrival notice gives additional details about the arrival and customs clearance process.


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