OT:RR:NC:RRTS:N3:135
Oscar Palacios
C.H. Robinson International
180 E. Ocean Blvd.
Long Beach, CA 90802
RE: The country of origin of drains, a connector, and an evacuator
Dear Mr. Palacios:
In your letter dated November 12, 2025, on behalf of your client, Degania Medical Devices Pvt., Ltd, you
requested a country of origin ruling on three drains, a connector, and an evacuator, which function in a closed
wound drainage system. Additional information was provided via various emails.
Item# 110065A2461ET (Round Drain W/O Trocar) is a 24 French, hubless, Blake fluted round drain
consisting of a silicone drain tube with four channels along the sides and a blue radiopaque stripe along the
length of the tube, and an adapter. The adapter is made in the United States.
Item# 110065C1961ET (Round Drain with Trocar) is 19 French, hubless, Blake fluted round drain consisting
of a silicone drain tube with four channels along the sides and a blue radiopaque stripe along the length of the
tube, an adapter, and a bendable trocar. The adapter and trocar are made in the United States.
Item# 111040B0761ET (Flat Drain with Trocar): is a flat, 3/4 fluted, 7mm, Blake drain consisting of a
radiopaque flat silicone drain tube with four channels along both sides, an adapter, a hub, and a trocar. The
flat drain is channelled along either 75% or 100% of its length. The adapter and trocar are made in the United
States. The hub is made in Israel.
Item# 11902661ET (Blake Cardio Connector) is a plastic connector used to connect drains with a suction d
evice (Evacuator). It is made in the United States.
Item# 31300661ET (Evacuator) consists of a silicone bulb, non-return valve, a bulb plug, a locking ring, and
a bulb cap. It acts as a suction device to collect unwanted fluid, blood, or puss. The bulb is made in India. The
bulb plug, non-return valve, locking ring, and bulb cap are made in Israel.
These items are individually packed and supplied non-sterile from India.
The manufacturing process for the first three items generally includes the following stages:
Production in Israel:
Radiopaque strips material and silicon main material are fed into separate extruders and then radiopaque
material is embedded in the silicon raw material through the extrusion die in Israel. The channels are formed
along the length of tube through extrusion dies during the extrusion process in Israel. The complete tubes are
exported to India.
Production in India:
Cutting:
The tubes are cut to precise lengths manually.
Component Assembly:
Trocars (where applicable) are manually glued to the drain tubes using specialized adhesives.
Hubs are manually attached to flat drains.
Curing and Stabilization:
Assembled components undergo curing by holding for a certain period of time under clean room
environment to stabilize adhesives and ensure structural integrity.
Curing times and temperatures are tightly controlled to meet medical device standards.
Cleaning and Surface Treatment:
Products are cleaned with IPA (Iso propyl Alcohol) to remove residues and particulates.
Surface treatments include ink-based DOT markings, which serve as a reference for catheter placement
at the surgical site.
Packaging and Labeling:
Each unit is individually packed in sterile or non-sterile pouches depending on customer requirements.
The adapter is placed inside the pouch with a drain as a separate component and it is not fitted with the
drain.
Labels, IFUs (Instructions for Use), and traceability codes are applied.
Packaging materials include LDPE rolls, protective surfaces, and pallets for bulk handling.
Quality Control and Final Inspection:
Finished products undergo rigorous QC checks including:
Dimensional verification
Adhesion strength testing
Visual inspection for defects
Functional testing (e.g., suction integrity for evacuators)
Products are batch-coded and logged for traceability.
The Blake Cardio Connectors are produced in the United States and packaged in India.
The production processes for the Evacuator in India includes the following:
Bulb assembly. The cap, bulb plug, and locking ring are manually attached together to form a cap
assembly. The valve is oiled. The cap assembly, valve, and bulb are assembled together by a machine.
Functionality tests include a pressure test, a vacuum test, a system test, and a ring test.
Cleaning and wiping.
Labelling and packaging.
Sealing and final inspection.
Box packing and final release by quality control.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
For Item# 110065A2461ET (Round Drain W/O Trocar), Israeli drain tubes are cut to precise lengths in India
and then packaged with the adapter. In Headquarters Ruling Letter (HQ) 734720, dated October 22, 1992,
CBP determined that cutting U.S. manufactured self-adhesive tape to length and width in Canada did not
substantially transform the tape into a product of Canada. Also see HQ 729316, dated April 20, 1989.
Similarly, the cutting process here does not change the name, character, or use of the Israeli drain tubes.
Furthermore, cleaning, DOT marking, packaging, labeling, quality control, and inspection are considered
minor finishing operations that do not result in a substantial transformation. Accordingly, the country of
origin for Item# 110065A2461ET will be Israel.
For Item# 110065C1961ET (Round Drain with Trocar) and Item# 111040B0761ET (Flat Drain with Trocar),
Israeli drain tubes are cut to precise lengths in India. These tubes are then manually glued with trocars,
undergo a curing process, and are subsequently packaged with the adapter. The cutting process does not
change the name, character, or use of the Israeli drain tubes. Similarly, gluing the tubes and trocars together
with adhesive, and the subsequent stabilization of the adhesive over a set period to ensure structural integrity
are simple processes that do not constitute a substantial transformation. Furthermore, cleaning, DOT
marking, packaging, labeling, quality control, and inspection are considered minor finishing operations that
do not result in a substantial transformation. In this case, no component undergoes a substantial
transformation in India. We find that the fluted drain tube is the essence of both products. The primary
function of drainage relies on the drain tube. While the trocar is important for initial placement, it is removed
once the drain is properly positioned and does not contribute to the ongoing drainage function. Accordingly,
the country of origin for both items will be Israel.
For Item# 11902661ET (Blake Cardio Connector), the U.S.-origin Blake Cardio Connectors are merely
packaged in India. The packaging process does not cause a substantial transformation. The country of origin
of this item will be the United States.
For Item# 31300661ET (Evacuator), the assembly of the evacuator and the manufacture of the bulb in India
constitutes a substantial transformation. The country of origin of this item will be India.
The question of the applicability of the U.S. content exemption under heading 9903.01.34, HTSUS, is being
referred to U.S. Customs and Border Protection, Regulations & Rulings, 90 K Street, NE – 10th Floor,
Washington, DC 20229-1177. A ruling will be issued to you from that office.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
Deborah Marinucci
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division