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HQ 085419

January 26, 1990

CLA-2 CO:R:C:G 085419 LS


TARIFF NO.: 6210.10.4010

Robert F. Seely
Katten Muchin & Zavis
525 West Monroe Street
Suite 1600
Chicago, Illinois 60606-3693

RE: Tariff classification of two types of nonwoven disposable coveralls made of Tyvek spun-bonded olefin

Dear Mr. Seely:

This is in response to your initial letter, dated August 4, 1989, requesting a tariff classification ruling on two types of nonwoven disposable coveralls made of Tyvek fabric. Your request was submitted on behalf of Baxter Healthcare Corporation.


The facts have been presented in the form of three letters, dated August 24, 1989, September 6, 1989, and December 19, 1989. The letter of August 24, 1989 was accompanied by several exhibits, including advertising brochures.

The two types of nonwoven disposable coveralls are made of Type 14 Tyvek. Type 14 Tyvek is a virtually impermeable nonwoven fabric made of high density polyethylene fibers which are bonded together with heat and pressure. When used to make garments, Type 14 Tyvek serves as an effective barrier in environments such as clean rooms, hospitals, clinics, laboratories, and contaminated areas. Type 14 Tyvek's effectiveness is due to some of the following characteristics. Its continuous polyethylene fibers are non-absorbent and essentially inert chemically and biologically. Tyvek has high tensile/tear strength in all directions because its continuous fibers are spunbonded in all directions. It is equally strong when wet or dry. Tyvek also has good puncture and abrasion resistance and is static- resistant.

The first type of disposable coverall is known as "Sterile Micro-Clean 212." It is made of Type 1422R Tyvek which means that it is corona discharge treated so that it can be printed by a flexigraphic process. The fabric is then coated with a polyamide film, known as the 212 Micro-Clean coating, which gives the fabric a bluish-white appearance and increases its barrier protection properties. This coating is said to incorporate the following unique features. First, it serves as an unusally effective antistatic agent. Second, it provides a high level of protection against the passage of particulates. Nearly 99 percent of particles of 0.5 micron diameter and larger are filtered out. Third, the coating results in the lowest available level of releasable particles caused by material shedding or lint. Lastly, the coating provides superior resistance to chemicals. The garments also provide wearer comfort because of their high water vapor transmission rate. The Micro-Clean 212 garments are marketed and sold in sterile and unsterile conditions. They are sewn in Mexico and shipped to the United States for sterilization and individual packaging in sealed polyethylene bags. Sterilization is accomplished by gamma ionizing radiation which results in maximum sterility assurance. The Sterile Micro-Clean 212 one-piece coverall has long sleeves, a zippered front, and a stitched collar. The garment has double- sewn bound seams which are placed at low stress points. For example, the arms are seamed across the chest portion rather than at the arm pits. The garment also has elastic closures at the ankles and sleeves which are encased within the fabric.

You state that the Micro-Clean 212 coveralls are marketed for use in industrial clean rooms, and that most of them are sold for use in the semiconductor, pharmaceutical, aerospace and biotechnology industries. Large quantities of the sterile coveralls are purchased by pharmaceutical laboratories. The garments serve two essential functions when worn in clean rooms. Primarily, they provide the necessary barrier protection between the worker and the environment to ensure the purity of the product made in the clean room. For example, in the semiconductor industry the garments prevent particles, including body particles and dust which are 0.5 micron and larger, from contaminating integrated circuits. Such contamination would cause an electrical short-circuit or malfunction. Secondarily, the garments protect the wearer against possible injury or contamination from materials used in the clean room. For example, in biotechnological applications the garment would
guard against carcinogenic substances that could be absorbed through the skin. In very demanding clean room environments, the disposable coveralls are used in conjunction with eyes-only or open-faced hoods, high top shoe covers, and gloves. You state that the subject garments are manufactured under the "good manufacturing practice" requirements for medical devices established by the Food and Drug Administration (FDA) and set forth in 21 CFR 820.1-.198, even though compliance with such practice is not required.

The second type of garment at issue is the "General Use" disposable coverall. These garments are made of Type 1422A Tyvek which is uncoated and white in color. Unlike the Micro-Clean 212 garments, the fabric of the "General Use" coveralls is not corona discharge treated and is not coated with a polyamide film. The garments are usually worn one time and discarded. In some cases they can be used a second time if the particular application permits. The two samples submitted (Samples B and C) have long sleeves, a zippered front, and a stitched collar. Only Sample C has elastic closures at the wrists and ankles. The "General Use" coveralls are marketed for use in hospitals, clinics, laboratories, and contaminated areas by the Hospital Supply Division, Industrial Products Division, and Scientific Products Division of the Baxter Healthcare Corporation. When used in medical facilities, the garment provides an excellent barrier against accidental contact with contaminated fluids, such as blood, and other biological or chemical agents. The coveralls are also marketed for use in those clean room environments which do not require the exceptional antistatic features, barrier protection, and sterility offered by the Micro-Clean 212 garments. In non-clean room applications, the "General Use" coveralls are worn for purposes of two-way barrier protection. For example, in the food processing industry, they are selected because the Tyvek 1422 grade fabric is not a medium for bacterial growth and therefore the garment protects both the product and the wearer against bacterial infection. The "General Use" garments are also manufactured according to the FDA standards for "good manufacturing practice," even though compliance with those standards is not mandatory.

You claim that both garments are classifiable in subheading 6210.10.4010 of the Harmonized Tariff Schedule of the United States (HTSUSA) as garments "Of fabrics of heading 5602 or 5603: Other: Nonwoven disposable apparel designed for use in hospitals, clinics, laboratories or contaminated areas." An affidavit of one of your employees states that the TSUSA equivalent of this statistical breakout was intended to cover all garments made of Tyvek fabric which were at that time being imported from Mexico. These garments were being sold for use in hospitals, clinics, laboratories, and clean rooms.


What is the applicable tariff classification under the HTSUSA for the subject garments?


The scope of subheading 6210.10.4010, HTSUSA, and one of its predecessor provisions under the TSUSA, item 384.9305, has been addressed in two prior rulings. In HRL 084164, dated September 20, 1989, a garment made of Type 1422A Tyvek was classified in item 384.9305, TSUSA, which provides for "Other women's, girls, or infants' wearing apparel, not ornamented: of man-made fibers: Not Knit: Other: Other: Nonwoven disposable apparel designed for use in hospitals, clinics, laboratories, or contaminated areas." The ruling also stated that the garment was classifiable in subheading 6210.10.4010, HTSUSA. The garment in that case was primarily sold for use in "contaminated areas" to protect individuals from contaminants in the environment, such as asbestos, radioactive dust, pesticides, and viral agents which have plagued the poultry industry. The importer, Texel Industries, Inc., also mentioned use of the garment in clean room applications and laboratories. In HRL 085360, dated December 13, 1989, we found that a one-piece coverall made of 100 percent spun-bonded polypropylene with elastic closures on the wrists and with an attached hood and boots was classifiable in subheading 6210.10.4010, HTSUSA. This garment also had a seam sewn across the chest rather than under the arms. The importer sold the garment solely for use in asbestos abatement work.

Relying on these earlier rulings, we find that the Sterile Micro-Clean 212 garment is classifiable in subheading 6210.10.4010, HTSUSA, as "nonwoven disposable apparel designed for use in hospitals, clinics, laboratories or contaminated areas." The clean room uses are encompassed within the term "contaminated areas" because they are areas where contamination of products from dust and body particles, such as flaking skin, dandruff, lint, salt, and dead tissue, is carefully controlled. Because the products manufactured in clean rooms are sensitive to environmental contamination, it is necessary to wear special clothing, such as the instant Tyvek garments, which are designed as an effective shield against the penetration or passage of various minute particles. As explained above, these garments also serve the secondary purpose in clean rooms of protecting the wearer against contamination from harmful substances. The Sterile Micro-Clean 212 coverall has the following special design features which adapt it for clean room use: the use of Type 1422R Tyvek material, a polyamide film coating, double-sewn bound seams placed at low stress points, sterilization by gamma ionizing radiation, and elastic closures at the ankles and sleeves.

The General Use coveralls are also classifiable in subheading 6210.10.4010, HTSUSA. The primary special design feature is the use of Type 1422A Tyvek fabric. Sample C has the additional design feature of elastic closures on the wrists and ankles. For the same reasons as discussed above, these garments are designed for use in clean rooms, which fall within the scope of the term "contaminated areas." These coveralls are also designed to be used in medical facilities because they provide an effective barrier against biological and chemical contaminants.


For the foregoing reasons, the Sterile Micro-Clean 212 coverall and the General Use coveralls are classifiable in subheading 6210.10.4010, HTSUSA, as "nonwoven disposable apparel designed for use in hospitals, clinics, laboratories or contaminated areas." The rate of duty is 17 percent ad valorem.

Due to the changeable nature of the statistical annotation (the ninth and tenth digits of the classification) and the restraint (quota/visa) categories, you should contact your local Customs office prior to importation of this merchandise to determine the current status of any import restraints or requirements.


John Durant, Director

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