CLA-2-30:OT:RR:NC:2:238
Mr. Christopher Pey
Meeks, Sheppard, Leo & Pillsbury
1735 Post Road, Suite 4
Fairfield, Connecticut 06824
RE: The tariff classification of pledgets imported in retail packaging from Mexico
Dear Mr. Pey:
In your letter dated September 30, 2014, on behalf of Ethicon, Inc., you requested a tariff classification ruling. Representative samples were submitted with your request and will be retained by this office.
The products to be imported are non-sterilized, nonabsorbable Polytetrafluoroethylene (PTFE) Polymer Pledgets in retail packaging for sale to hospitals and surgical suites. You provided a representative sample of PCP 20. This package contains 6 pledgets measuring 7 mm x 3 mm x 1.5 mm. You state that subsequent to importation, the pledgets will remain in their original retail packaging and undergo sterilization by an ethylene oxide gas process which infiltrates the retail packaged pledgets and kills microorganisms. The subject pledgets are available in both hard and soft forms.
These pledgets, also referred to as suture buttresses, are used to prevent sutures from tearing through friable tissue. In addition to lending support to the tissue, it also reduces or prevents bleeding at the sutured wound site by compression. They are commonly used in cardiac surgery for vascular closure, septal repair, myocardial heart and valve suturing, but may also be used in hepatic repair or abdominal wall closure.
The applicable subheading for the pledgets imported in retail packaging will be 3005.90.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Other: Other: Other." The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
Your inquiry does not provide enough information for us to give a classification ruling on the hard and soft pledgets imported in bulk form. Please provide the following information:
1. Are the hard and soft pledgets manufactured from exactly the same fabric?
2. Provide the generic name in English of each fiber in the fabric and indicate its relative weight as a percentage of the fabric.
3. Indicate whether the fibers are staple or filament.
4. What is the weight of the fabric in grams per square meter, before and after processing and making into the pledgets?
5. In a previous letter, you described the hard pledgets as felt impregnated with PTFE dispersion and the soft pledgets as regular felt. However, you also stated that both the hard and the soft pledgets are made from the same nonwoven felt fabric constructed from the interlacing / entangling of long PTFE-polymer fibers. Does this mean that the hard version has an extra layer, coating, etc., of PTFE or any other material or substance? Please state whether or not each type of pledget or the fabric from which they are made are coated, covered or impregnated with any substance, and describe that substance. Explain in detail every additive or treatment that contributes towards the extra rigidity of the hard pledget.
6. Provide two samples, at least 18” by 18” in size, of each of the fabrics used in the manufacture of the pledgets.
7. Provide a step-by-step detailed description of how the felt fabrics are made.
8. Provide a step-by-step detailed description of how each type of pledget is made. Based on the processing steps provided with your request, it appears that the soft pledgets are cut to length and then width, while the hard pledgets are die cut to shape. Please confirm or clarify. At what point are the holes made in the pledgets? Are the holes cut during the die cutting operation, or as a separate operation?
When this information is available, you may wish to consider resubmission of your request. If you have any questions regarding these questions, contact National Import Specialist Maribeth Dunajski at [email protected].
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division