CLA-2 RR:CR:TE 961683 SG

Ms. Maria de Jesus Monarrez
Account Manager
Rudolph Miles & Sons, Customs Brokers
4950 Gateway East
P.O. Box 11057
El Paso, Texas 79983-1057

RE: Classification of a surgical drape known as a "Univeral Drape"; Composite good: Essential character determination; GRI 3(c)

Dear Ms. Monarrez:

This is in response to your correspondence of March 20, 1988, and August 10, 1999, in which you requested, on behalf of your client, Bemiss-Jason Corporation, a tariff classification ruling under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) for a surgical drape manufactured in Mexico. You submitted a sample of the drape along with your request. We apologize for our delay in responding.

FACTS:

You advise that your client has contracted with an unrelated Mexican company to produce a surgical drape. Your client sells this drape as a "Universal Drape" which is used primarily as a surgical drape in cardiac procedures such as angiograms, balloon angioplasty, insertion of stints, and insertion of pacemakers. It is very common that patients begin with a general angiogram and then proceed into one of the other procedures. These procedures can be very lengthy and messy. You advise that a strong selling point of this drape is that it can withstand multiple procedures performed consecutively due to the full-length absorbent lamination and the sterile field protection.

The drape is composed of four layers of different materials. All four layers are purchased by your client from companies that produce the materials in the United States. You describe the layers as follows:

Layer #1 is a polyethylene film that has been stretched during production to produce small apertures whose main function is to allow fluids to flow to the absorbent layer underneath. It also keeps lint from the absorbent layer from reaching the patient. The blue color absorbs light from the overhead lamps and reduces glare for the doctor.

The product name of layer #1 is Delnet* and it is made in Delaware. It is 33.25 inches wide, high density polyethylene, 4.8 mils. thick, and weighs 13.6 grams per square meter.

Layer #2 is an absorbent nonwoven material. Its main function is to absorb all fluid expelled during the procedures.

It is a white, unembossed air laid fabric composed of bleached virgin wood pulp fibers and bonded with a latex binder. This material is made by "fiberizing" cellulose (wood) pulp in a series of hammemills. The fiberized pulp is then blown onto a wire screen running through an air laid machine. Each side of the web is sprayed with a binder to hold the fibers in sheet form. The web is then slit to 32 inches wide and wound into rolls. It has an average basis weight of 97 grams per square meter. It is 72.5 mils. thick and has an absorbency rate of .5 seconds/ml. This material is made in Green Bay, Wisconsin.

Layer #3 is a polyethylene film whose main function is to act as a barrier for fluid leakage to the patient. In extended procedures there is the potential for large amounts of fluid to be expelled. If these fluids can soak through the drape, the sterile field will be compromised and the drape must be changed. The film extends down the procedure table on each side acting as a sterile field covering the table controls. This gives the doctor high visibility of the controls during the procedure.

This product is 2 mils. thick, and weighs 3.14 grams per square meter, clear in color, low-density polyethylene film which is 75 inches wide. This layer is made in Georgia.

Layer #4 is a print bonded polyester. It is laminated to the bottom side of the drape and acts as a comfort layer between the patient and the polyethylene film (layer 3). This fabric is manufactured in Arkansas.

You advise that the layers are laminated together by a water-based adhesive and wound into rolls. The lamination process is performed at your client's facility in Texas. The laminated material is cut to either 110 inch or 125 inch lengths, packaged, and sent to Mexico.

In Mexico the laminated product is made into completed surgical drapes. The drapes are fenestrated (two die-cut circles cut out of material at various placements). Adhesive tape is applied around the fenestrations. During the medical procedure, the fenestrations are placed over the patient at the intravenous point of entry (usually the groin, but may be other parts of the body). The tape keeps the drape attached to the patient and holds the drape steady. Liners are applied to the tape to keep it from sticking to the other parts of the drape. These liners are discarded during the patient preparation before the operating procedure. The drape is fan-folded and packaged in a shipping carton. The finished drapes are then shipped to Texas.

In the United States, the majority of the drapes are sold to medical kit packers who add the drape to a kit that contains all components needed to perform cardiac procedures. Most of these customers will sterilize the kit and sell it to hospitals and clinics. You advise that a small number of the drapes are sold by your client directly to hospitals and/or clinics. Sterilization will be performed after importation.

ISSUE:

Is the surgical drape "Universal Drape" classifiable as a paper product under subheading 4818.90.00, HTSUS (hospital article), a textile article under subheading 6307.90.60, HTSUS (surgical drape), or a plastic article under subheading 3926.90.98, HTSUS (other plastic articles)? Is it eligible for duty free treatment under NAFTA?

LAW AND ANALYSIS:

I. Classification

Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRI's). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative section or chapter notes. Where goods cannot be classified solely on the basis of GRI 1, the remaining GRI’s will be applied.

In interpreting the headings and subheadings, Customs looks to the Harmonized Commodity Description and Coding System Explanatory Notes (EN’s), which are not legally binding, but are recognized as the official interpretation of the Harmonized System at the international level. It is Customs practice to follow, whenever possible, the terms of the EN’s when interpreting the HTSUS.

The surgical drape is comprised of four layers of four different materials, two of which are plastic (polyethylene film), one is paper (wood pulp), and one is textile (bonded polyester). Customs has previously classified surgical drapes under headings 3926, 4818, and 6307, HTSUS, depending on whether they were made of plastic, paper or textile material. However, a review of the HTSUSA indicates that there is no single heading that describes the article. Thus, the surgical drape is not classifiable pursuant to GRI 1.

GRI 2(b) states that the classification of goods consisting of more than one material or substance shall be according to the principles of GRI 3. Since the surgical drape consists of paper, plastic, and textile components, the drape is classified according to the principles of GRI 3.

GRI 3 describes a hierarchy of methods of classifying goods that fall under two or more headings. The first method of classification is provided in GRI 3(a), under which the heading which provides the most specific description is to be preferred to a heading which provides a more general description. However, when two or more headings each refer to a part of materials or substances contained in composite goods, those headings are to be regarded as equally specific in relation to those goods, even if one of them gives a more complete or precise description than the other. In this case the headings under consideration are heading 3926, HTSUS, where we have put drapes composed of material of heading 3920, HTSUS [plastic], heading 4818, HTSUS, where we have put drapes composed of material of heading 4803, HTSUS [paper], and heading 6307, HTSUS, where we have put drapes composed of material of heading 5603, HTSUS [textile]. Since the drape is a composite good and each of the headings under consideration only cover a part of the materials contained in the surgical drape (paper, plastic, and textile), GRI 3(a) is not determinative of the classification of the drape. In such circumstances, the GRI directs that the classification of such goods shall be determined by GRI 3(b) or (c).

GRI 3(b) provides that composite goods consisting of different materials or made up of different components are to be classified as if they consisted of the material or component which gives them their “essential character.” Explanatory Note VII to Rule 3(b). Thus, the question is whether the paper, plastic, or textile component of the drape gives the article its essential character. Essential character may be determined by the nature of the material, its bulk, quantity, weight, value or by the role of a material in relation to the use of the goods. Explanatory Note VIII to Rule 3(b).

The function of layer 1 is to allow fluids to flow to the absorbent layer underneath; the function of the paper material comprising layer 2 is to absorb all the fluid expelled during the cardiac procedures; the main function of layer 3 is to act as a barrier for fluid leakage to the patient, and to keep the sterile field uncompromised; layer 4's function is as a comfort layer. The drape can withstand multiple procedures performed consecutively due to the full-length absorbtion lamination provided by layer 2, and the sterile field protection provided by layer 3. It is the combination of these two layers that allows the drape to function as intended. Inasmuch as layers 2 and 3 allow the drape to carry out its intended function, it is these two layers that are to be considered of primary importance in comparison to the remaining layers (layers 1 and 4). With regard to the subject merchandise, it is impossible to determine which of its components (layer 2 or 3) determines this article's essential character: both make significant contributions to the product, both are essential to the function of the surgical drape, and the contribution of the paper component does not so outweigh the plastic contribution so that it clearly imparts this product's essential character. GRI 3(c) sets forth that when goods cannot be classified by reference to 3(a) or 3(b), they shall be classified under the heading which occurs last in numerical order among those which equally merit consideration. Accordingly, the article at issue is properly classified under the relevant heading of Chapter 48, HTSUS, as this heading occurs later in numerical order than does the relevant heading of Chapter 39, HTSUS.

Heading 4818, HTSUSA, covers, inter alia, "handkerchiefs, cleansing tissues, towels, tablecloths, table napkins, diapers, tampons, bed sheets and similar household, sanitary or hospital articles, articles of apparel and clothing accessories, of paper pulp, paper, cellulose wadding or webs of cellulose fibers." We find that the provision for similar hospital articles of paper: other, in subheading 4818.90.0000, HTSUSA, applies to the instant surgical drape.

HOLDING: The instant surgical drape known as a "Universal Drape" is properly classified in subheading 4818.90.0000, HTSUSA, the provision for "Toilet paper and similar paper, cellulose wadding or webs of cellulose fibers, of a kind used for household or sanitary purposes, in rolls of a width not exceeding 36 cm, or cut to size or shape; handkerchiefs, cleansing tissues, towels, tablecloths, table napkins, diapers, tampons, bed sheets and similar household, sanitary or hospital articles, articles of apparel and clothing accessories, of paper pulp, paper, cellulose wadding or webs of cellulose fiber: Other", dutiable at the general rate of 0.6 percent ad valorem.

Sincerely,

Myles B. Harmon, Acting Director
Commercial Rulings Division