How to Import Nitrile Gloves

Work with USA Customs Clearance customs bond experts to import surgical gloves and other PPE to the United States today.

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Randy Hauck
March 27, 2020
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Many essential medical supplies are in short supply in today’s current environment. One of the ways to limit this shortage is to import surgical gloves. These crucial items are needed to protect medical personnel, patients, and more. When importing surgical gloves, there are important details that need to be considered. This includes government regulations, customs clearance, tariffs, and more. All of these factors show why it’s important to work with a trusted partner to quickly and successfully import surgical gloves. 

USA Customs Clearance, powered by AFC International, offers personal customs consulting services to help you import surgical gloves. We provide you with all of the information you need to successfully import your vital goods. You’ll get the advice you need and we’ll handle the rest. 

Need help importing surgical gloves into the United States?
Consult with our Licensed Customs Brokers to get the help and answers you need.

What is the Import Duty for Nitrile Gloves?

Nitrile gloves are part of a larger group of medical gloves that includes examination gloves and special chemotherapy gloves designed specifically for handling chemotherapy products. All of these gloves are considered personal protective equipment, according to the U.S. Food and Drug Administration. These medical gloves aid healthcare workers and patients by protecting their hands from infectious germs in places and situations when infection is likely. 

There is no import duty on nitrile gloves imported into the U.S. However, using the wrong tariff classification code for your gloves can lead to incorrectly being assesed an import duty. Our team of Licensed Customs Brokers work with you to ensure that products are accurately classified with the correct HTS code. This ensures your gloves are imported duty free.

What About Nitrile Gloves From China?

A large number of surgical and medical gloves are imported from China into the U.S. each year. In 2018, the U.S. government applied additional tariffs on nearly all goods imported from China. These new restrictions significantly impacted trade between the two world powers. 

In early March 2020, the U.S. began granting exemptions for vital medical supplies including gloves imported from China. This action lowered the barrier to bring these important goods into the country. 

Even with no import tariffs, it’s still crucial to work with an experienced partner like USA Customs Clearance. We make the import process easy and smooth with no interruptions to your critical supply chain.

FDA Guidelines When Importing Nitrile Gloves

fda-guidelines-when-importing-surgical-gloves

As noted above, surgical gloves are grouped together with other types of medical gloves according to the FDA. All of these gloves are further classified as personal protective equipment (PPE). This large classification encompasses a variety of products that are meant to prevent the spread of infection, illness, and injury. Examples of PPE include facemasks, helmets, protective clothings, goggles, and more. 

Once your surgical gloves have been approved by the FDA, you can initiate the import process. Many importers choose to speak with an import export consultant at this point. Working with an import consultant reduces the likelihood that major troubles will arise during the import. This includes complete loss of goods due to seizure by CBP, which many importers experienced shortly after the global pandemic hit.

If you're unsure about the import compliance of your shipment, it's always recommended to utilize the services of an experienced customs broker. USA Customs Clearance and our team of licensed brokers are here to help you every step of the way.

Does the FDA Require a 510K For Nitrile Gloves?

Nitrile gloves, including for surgical use, are categorized as class 1 medical devices. This means they’re regulated by the FDA and require a 510(k) premarket notification. The FDA reviews the gloves to insure that they meet specific criteria related to safety and performance. 

It's important to note that many nitrile gloves have already received approval through a 510K. If you're importing nitrile gloves that have already been approved, then you won't need to go through the 510K process. You'll simply need to reference the 510K to show the gloves you're importing have already been approved.

Using Consulting Services When Importing Nitrile Gloves

As noted above, consulting with a customs expert is an advisable part of the importing process. There are many details that can be overlooked which can lead to unwanted fees or delays of your shipment. An experienced customs broker will have the necessary knowledge and experience to ensure this doesn’t happen to your valuable goods.

USA Customs Clearance, powered by AFC International, offers 2 convenient options for customs consulting. You can consult with an Import Expert or a Licensed Customs Broker. Our Import Expert consulting session is recommended for those that have little to no experience in importing. We’ll walk you through the entire process from start to finish, giving you a full understanding of how importing goods works. If you still need more time with our experts, we can craft a custom solution to meet your needs. 

If you have some experience in importing goods, but haven’t dealt with surgical gloves before, meeting with a Licensed Customs Broker might work for you. Our Licensed Customs Broker will give you everything you need to know to successfully import your surgical gloves. We’ll go over how to make sure your shipment complies with FDA standards and more. 

Regardless of which option you choose, at the end of your consulting session you’ll have everything you need to ensure a hassle-free import. 

Need help importing surgical gloves into the United States?
Consult with our Licensed Customs Brokers to get the help and answers you need.

Do I Need a Customs Bond to Import Nitrile Gloves?

do-i-need-a-customs-bond-to-import-surgical-gloves

One of the most important aspects of the import process is ensuring you have a customs bond when necessary. A customs bond is required when importing $2,500 or more of commercial goods. This is also required when goods being imported are regulated by government agencies. Therefore, a customs bond is required when importing surgical gloves. 

If you’ve never imported goods before, the purpose of a customs bond may be unclear to you. A Customs bond acts as an insurance policy to ensure that all fees and duties associated with an import shipment are paid. It’s an agreement between the company supplying the bond, the import of record and U.S. Customs and Border Protection (CBP). 

USA Customs Clearance offers continuous customs bonds which cover all imports within 1 year of the bond’s issue date. With same day approval for a customs bond, we can get your import moving quickly and into the hands of people that need them.

Make sure your upcoming import of gloves is secure.
Purchase a customs bond to avoid issues and delays at the border.

What Other Documents Are Needed When Importing?

In addition to a customs bond, there are other essential documents needed for the import process. 

Other documents you’ll need when importing include:

  1. Packing List: This shows important details about what’s inside of a sealed package including quantity of products, dimensions, weight, and more.
  2. Bill of Lading: This document serves as a receipt of shipment for the receiver, shipper, and carrier.
  3. Arrival Notice: This document is required to be transmitted electronically to customs officials prior to arrival in the U.S. A paper copy that matches the electronic data should also accompany the shipment.
  4. Commercial Invoice: Information including value of the goods, HTSUS number, detailed product descriptions, and more are included on the invoice.

Missing or inaccurate documents can lead to a delayed shipment or unplanned customs fees. USA Customs Clearance will work with you to make sure your import shipment has all of the required documentation. Whether you're importing face masks, surgical gloves, or another critical need product, we'll ensure your goods arrive quickly and without issue.

Schedule a Customs Consulting Session

Trying to import surgical gloves in the current state of the world can be a daunting task. Luckily, USA Customs Clearance is here to help guide you through the process. From gathering and completing all of the required paperwork to clearing your goods at the border, we’ll be with you every step of the way. We’ll make the import process easy and hassle-free to ensure your surgical gloves reach the people in need quickly. 

Schedule your customs consulting session with USA Customs Clearance today. Our knowledgeable and experienced consultants are ready to assist you with your surgical gloves import.

Need help importing surgical gloves into the United States?
Consult with our Licensed Customs Brokers to get the help and answers you need.
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20 comments on “How to Import Nitrile Gloves”

  1. i am going to import nitrile gloves from China to UsA. The manufacturer needs a 510k? Also the importer or buyer needs a 510K? who needs it.

    1. Hi Kevin,

      A 510K is generally needed for medical devices that are marketed and sold in the U.S. However, due to the current situation in regards to the global pandemic the FDA has made some temporary exceptions to this rule. We've responded privately with additional information. We look forward to working with you!

  2. Hi Sir/ Madam,

    Good Day to you!

    I am in the midst of exporting 15k boxes (1.5k carton) Nitrile Examination Gloves to America, the product consist of FDA approval. I just want to ask the below two questions:

    a) Document needed such as Country of Origin (COO)?

    b) The product box behind never state the manufacturer but it did state the endorsement by the US & EU Representative namely (removed for privacy), Germany respectively. Of course, we have the sufficient and legit documents to prove this product is from this manufacturer. With the above mentioned, is it still able to import to America?

    Kindly clarify and sincerely thank you for the respond!

    1. Hi Cyril,

      We've responded privately with the information you requested. We look forward to assisting you.

    1. Hi Adil,

      The CBP and FDA are handling some of these excpetions on a case by case basis due to the immense need for medical supplies including nitrile gloves. We strongly recommend consulting with a Licensed Customs Broker before proceeding with importing your gloves.

      Consult with our Licensed Customs Brokers to get the help you need. We look forward to assisting you.

  3. Greetings.

    I am reseller for NITRILE GLOVES from a Thailand manufacturer. I have buyers who want to buy and export to Los Angeles a sum of 20million boxes of Nitrile gloves. I would like to know the certifications and the procedure required to export the above from Thailand to Los Angeles or any state in the US.

    I thank you for your information.

    1. Hi Uma,

      You'll need to comply with all standard customs requirements including covering your shipment with a customs bond. Additionally, depending on the intended use of the gloves (medical vs. non-medical) you'll need to provide additional documentation and ensure the proper labeling guidelines are followed.

      We've reached out privately with additional information that will assist you further. We look forward to working with you.

  4. Dear Sir /Madam,
    I am looking to import nitrile gloves and other medical items from China - what duty is applicable for gloves and PPE in general from China to the USA? Do I have to register my company in the USA as an importer of PPE? If so, how would I do so?
    Kind regards,
    Mark

    1. Hi Mark,

      The import duty for your items will depend on the specific HTS code that's applicable for your products. One of our Licensed Customs Brokers can assist you with this. We've responded privately with the informaionyou requested related to becoming a registered importer also. We look forward to assisting you!

  5. Gentlemen,

    I would be importing about 200,000 boxes of Nitrile medical exam gloves from Vietnam or probably Thailand and I would like to contract your custom clearance services. Can you please tell me the rates I would need to pay for your fees once the good arrive in Los Angeles and the corresponding tarrif I would need to pay (if any).

    Also, I would like to know if non-medial face masks such as kn95 pay any import duties when coming from China.

    Look forward to your prompt answer and thanks so much for your prompt answer.

    1. Hello Mario,

      In order to provide you with the tariff information that you're requesting, one of our Licensed Customs Brokers will need to properly classify the HTS code of the products that you're looking to import.

      We've responded privately to your message with this information, as well additional details that you requested. We look forward to working with you!

    1. Hi Tarek,

      We've privately with the information that you requested. We look forward to working with you!

    1. Hi Grace,

      We've reached out privately to provide you with this information. We look forward to working with you!

  6. Some people told me Disposable Nitrile Gloves from Vglove and Top Glove and are banned recently by US Customs. Is it true?

    1. Hi Tom,

      Gloves manufactured by WRP Asia Pacific Sdn. Bhd were banned from being imported in September of 2019. However, this ban was lifted on March 23, 2020. VGlove and Top Glove haven't had any bans recently and are currently allowed to be imported.

      If you're looking to import nitrile gloves and have further questions or need assistance, our Licensed Customs Brokers are available to help you. You can reach out to them at (855)912-0406 or schedule a consulting session today. We look forward to assisting you.

  7. I am looking to import into USA - General purpose hospital use NITRILE GLOVES from Malaysia & Vietnam.Kindly advise me is there any import Duty on this item and what are the other official requirements to import this item.Thanks.

    1. Hi Zameer,

      In most cases, there is no duty rate for this product. However, depending on the size, material construction, and country of origin a duty rate may apply and will typically range from 3-4%. If your gloves are intended for hospital use, they'll need to be in compliance with all FDA requirements.

      Our Licensed Customs Brokers can further advise on your upcoming imports and ensure that everything is properly in place to avoid unnecessary charges or delay of your goods. You can schedule a customs consulting session with our Licensed Customs Brokers to get answers to all of your importing questions. We look forward to helping you, Zameer.

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