CLA-2 CO:R:C:G 085419 LS
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.
FACTS:
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.
-2-
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
-3-
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.
-4-
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.
ISSUE:
What is the applicable tariff classification under the
HTSUSA for the subject garments?
LAW AND ANALYSIS:
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.
-5-
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.
HOLDING:
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.
-6-
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.
Sincerely,
John Durant, Director
Commercial Rulings Division
6cc: A.D. Seaport
schreiber library/peh
085419LS