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How to import medical or surgical gloves into the U.S

Updated: May 26, 2020

I had a webinar training with U.S Customs The National Commodity Specialist Division of the Gloves' classification. I was amazed at how complicated the gloves can be. If you sort it by materials, there are plastics, rubber, leather, furskin, textile knit, or crocheted construction and some are mixed materials with two or even more. If you sort it by purpose, even with the same material, it could still be classified differently for different usage. It could be industry use, medical use, sports use., household use, toilet use, massage use, etc. If the gloves are made by knitted or crocheted textiles, it would be still classified differently based on the percentage of coated fabrics versus the real fabrics underneath so on and so forth~~

So you know, certain areas of product classifications require deep product knowledge. That is why you could not rely on your customs broker to give you any product tariff classification suggestions you think of.

it is said that the face masks market is gradually saturated but other PPE (Personal Protective Equipment) still has vast lucrative rooms to grow for importers & exporters worldwide. Let me share some information with you about importing medical/ surgical gloves today.

Highlight: Powered Gloves are banned in the United States

If the gloves, regardless of materials made, use powder to add to gloves to make them easier to take on and off, it is banned by the FDA to the United States!

Glove makers use to put powder on gloves as a lubricant to make donning the gloves easier. However, according to the FDA, when internal body tissue is exposed to the powder, it can cause severe airway inflammation and hypersensitivity reactions. Additionally, powder particles can trigger an immune response, causing the tissue to form around the particles, which can complicate surgeries.

This FDA Final ruling was effective on January 19, 2017. Importers who have no medical industry experience should be aware of it. When you decide to import the patient examination gloves or surgeon gloves, they need to be labeled as " UNPOWERED GLOVES" and Labeled in a manner not to produce an undue risk to public health

FDA regulations

The most commonly seen materials used in manufacturing medical/ surgeon gloves are nitrile, latex, and vinyl. Relevant FDA policies would apply to the following types of gloves. Check if yours is on the list

Once you know this is FDA regulated level gloves, review the following checklist for gathering the necessary information for custom clearance

  • Manufacture FDA registration number or FEI#

  • FDA Premarket (501k) number or approval that the gloves are classified as a 501k-exempt class I Devices ( Usually can be found in the FDA certificate)

  • Device Listing Number (Commonly known as LST# )

  • US Consignee’s TAX ID# so the broker can set up the consignee as Device Initial Importer (DII)

  • Accurately describes its sterility status and intended use in the commercials documents

I have mentioned in the previous article how to check FDA approved medical devices to prevent unauthorized suppliers scammer. Let me put the link here again for your reference

Unlike the face masks, FDA currently does not provide a list recommend suppliers of medical/surgeon gloves, it is importers' responsibility to check with the local health department or health professionals to ensure your supplier's gloves are up to the industry standards ATM D3577

Duty Rate of Medical/ Surgical Gloves

4015.1101.10: Surgical natural rubber gloves: Duty-free

4015.1101.50 Surgical gloves with materials other than natural rubber: Duty-Free

4015.1905.10 using Exclusion HS Code is 9903.88.39 or 9903.88.42: Medical gloves of natural rubber : Duty-free:

4015.1905.50 using Exclusion HS Code is 9903.88.39 or 9903.88.42: Medical gloves with materials other than natural rubber: Duty-Free

P.S, Sterile gloves are used primarily for surgical purposes. Sterile gloves must meet FDA standards based on an acceptable quality level of pinholes.

We have witnessed numerous historical moments in 2020. I do hope the pandemic will be over soon so we all have to get backs to normal life routines. Stay healthy and stay safe everyone!

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