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How to import medical gowns

Although many states consider reopening business phase 1 from early June, the reality is coronavirus confirmed cases still increases rapidly each day. I urgently advise everyone not to mistake " Reopening Business" equals to " Coronavirus gets under the control." Especially over the past few days, mass protests over police violence in at least 75 U.S. cities have spurred concern that the gatherings will seed new outbreaks. I personally think we would see another outbreak perk after another 14 incubation period.

In this circumstance, personal protective equipment including gowns, gloves, masks, ventilators, etc would still be in high demand. Here I would like to share some insights about importing protective gowns in healthcare settings.

Look at the protection level not the name

A few of the many terms that have been used to refer to gowns intended for use in health care settings include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns. It is very confusing and the fact is they don't have unified definition to define each gown. So it is better just to look at the label and find out the protection levels you need. In general, there are 4 protection levels

  • Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit ( Class I)

  • Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab (Class I)

  • Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases( Class Ii)

  • Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery,  when pathogen resistance is needed or infectious diseases are suspected (non-airborne) ( Class II)

Do not assume the FDA has moved to a hands-off approach.

I heard some importers say FDA has losen its restrictions and requirements for the PPE products so that they can quickly fill in the PPE shortages. I would never encourage any importers holo such mindset and take the risk to import non-compliant goods. Remember the custom clearance you obtained at the time of the entry is always conditional release only. U.S Customs and FDA agency has up to one year to reevaluate the entry data and send you to notice of action to request additional documents for review.

FDA requirement Checklist for importing medical/surgical use protective gowns

  1. FDA Product code

  • Surgical gowns/ Toga (FYA)

  • Non-surgical isolation gowns ( OEA)

  • Surgical Apparel Accessory (LYU)

  • Patient Gown (FYB)

  • Surgical Isolation gown (FYC)

  • Surgical suits (FXO)

  • Surgical Dress (FYE)

2. Manufacture FDA registration number or FEI Number

3. Pre-market approval number if applicable

4. Device Initial Importer

5. Country of origin

6. FDA Importer

7. Quantity and value

8. Tariff Classification

The duty rate for protective gowns for medical use is FREE

Tariff number 6210.10.5000, which provides for Nonwoven disposable apparel designed for use in hospitals, clinics, laboratories or contaminated areas .The duty rate is 0% ad valorem

if your product is made in China, please ensure you use the exclusion number 9903.88.42 to waive the additional section 301 list 4A duties.

The duty rate for the protective gown not for medical use

Lately, some importers send me the quote request of non-medical protective gowns. If the gown is not intended for healthcare settings, it will be treated as a regular textile category.

One of the possible tariff classifications is as below

Tariff # 6210.1090.10, which provides for 16% duty rate ad Valorem

Tariff Description: Garments, made up of by non-woven, Rubber thread and cord, Metalized yarn, Gimped yarn, felt and alike : Other: Other: Other, Overalls and coveralls

If the product is made in China, it is subject to the additional action 301 list 4A duties for 7.5%

If you are a buyer looking for KN95 Mask, hand sanitizer, hand soaps, protective gowns, antibacterial wipes, face shields, please PM me and i will connect you to the direct seller.

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