surgical gut suture for sewing
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 3006100100 | 10.0% | CN | US | Official Doc |
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𧡠Surgical Gut Suture for Sewing (Sterile Absorbable Suture)
π HS Code Reference & Clearance Guide | 2026 Latest Tariff Analysis | Professional Customs Strategy
π I. Product Definition & Classification: What is "Surgical Gut Suture for Sewing"?
"Surgical Gut Suture" refers to sterile surgical catgut or similar sterile suture materials, typically made from natural collagen (sheep or cattle intestine) or synthetic absorbable polymers, used for ligating blood vessels and closing wounds in medical procedures.
Key Characteristics: - Material: Natural (gut) or synthetic (e.g., polyglactin 910, poliglecaprone 25). - State: Sterile, ready for surgical use. - Form: Thread/yarn, often with or without needles pre-attached. - Function: Absorbable wound closure; does not require removal.
β οΈ Critical Distinction:
- If the suture is sterile and intended for surgical wound closure, it falls under Chapter 3006.
- If it is non-sterile or intended for non-medical sewing (e.g., leather stitching), it may fall under different chapters (e.g., Chapter 54 or 63), but the query specifies "surgical," so we focus on 3006.10.01.00.
π¦ II. HS Code Classification Details (2026 Latest Tariff Authority Mapping)
| HS Code | Product Description | Applicability | Sterile? | Surgical Use? |
|---|---|---|---|---|
3006.10.01.00 |
Pharmaceutical goods: Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure | Medical devices, surgical supplies | β Yes | β Yes |
π Key Reminder:
- Must be sterile: Non-sterile sutures are classified differently (e.g., under Chapter 54 for textile yarns).
- Must be for surgical/dental use: Non-medical threads (e.g., embroidery floss, leather thread) are not covered here.
- Includes absorbable materials: Even if not traditional "gut," synthetic absorbable sutures (e.g., Vicryl, Monocryl) fall under this code if sterile and surgical.
π° III. 2026 Latest Tariff Rate Details (Including Surcharges, Policy Add-ons)
β Applicable Country: United States (US)
β Country of Origin: China (CN)
β Effective Date: From November 10, 2025 (and subsequent imports)
π― 1. 3006.10.01.00 ββ Sterile Surgical Catgut & Similar Sterile Suture Materials
| Item | Content |
|---|---|
| Base Tariff Rate | 0.0% (ad valorem) |
| Additional Tariff (Section 301 / IEEPA) | 0.0% |
| Total Tariff Rate | 0.0% |
| Tax Calculation | CIF Value Γ 0.0% = $0 |
| De Minimis Eligibility | β Not Applicable (Pharmaceutical/Medical Goods typically exempt from de minimis but subject to FDA/CFR regulations) |
| Legal Basis Path | Chapter 30, Note 4 β HS 3006.10.01.00 |
π Explanation:
- Base Tariff: 0% under US Harmonized Tariff Schedule for sterile surgical sutures.
- Additional Tariffs: No 301/IEEPA surcharges apply to this specific HS code (unlike electronics or steel).
- Total Rate: 0% β This is a tariff-free item under current US trade policy.
- Regulatory Note: While tariff-free, FDA approval (510(k) or PMA) and CFR Title 21 compliance are mandatory for importation.
π οΈ IV. Customs Clearance Practical Advice (Battle-Tested Pitfall Guide)
β 1. Required Documentation Checklist (All Mandatory)
| Document | Mandatory | Notes |
|---|---|---|
| β FDA Establishment Registration | βοΈ | Importer must be registered with FDA |
| β 510(k) Clearance or PMA Approval | βοΈ | Proof of medical device clearance for surgical sutures |
| β Certificate of Sterility | βοΈ | Issued by certified lab (e.g., ISO 11135/11137 compliance) |
| β Product Specification Sheet | βοΈ | Material, absorbability, strength, dimensions |
| β Commercial Invoice | βοΈ | Clearly state "Sterile Surgical Suture, HS 3006.10.01.00" |
| β Packing List | βοΈ | Detail sterile packaging integrity |
| β Bill of Lading/Air Waybill | βοΈ | Standard shipping document |
| β FDA Prior Notice | βοΈ | Must be filed before arrival (BDCS system) |
β 2. Declaration Tips (Key Mnemonic)
π₯ "Sterile + Surgical + Absorbable = 3006.10.01.00 | 0% Tariff, 100% Compliance!"
| Scenario | Correct Declaration | Incorrect Action |
|---|---|---|
| Sterile surgical catgut | 3006.10.01.00 |
Misclassify as "textile thread" β Higher tariff + FDA hold |
| Non-sterile suture for crafts | Not 3006.10.01.00 | Declare as surgical β FDA rejection |
| Sterile absorbable synthetic suture | 3006.10.01.00 |
Use wrong code β 5-10% tariff + penalties |
| Suture with pre-attached needle | 3006.10.01.00 |
Separate needle declaration β Complex, unnecessary |
β 3. Special Cases Handling
| Scenario | Handling Advice |
|---|---|
| FDA Inspection Hold | Ensure sterility certificates and 510(k) numbers are on invoice; delay may occur if docs missing |
| Lot Traceability | FDA requires lot numbers for recall tracking; include in declaration |
| Expiry Date | Sutures must have valid shelf life at time of import; expired goods rejected |
| Non-3006.10.01.00 Codes | If not sterile or not surgical, do not use this code; consult customs broker |
π V. Global Market Clearance Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification Required | Notes |
|---|---|---|---|---|
| πΊπΈ United States | 3006.10.01.00 |
0% | FDA 510(k)/PMA, Sterility Cert | Tariff-free, strict FDA |
| π¨π³ China | 3006.10.01.00 |
0% | NMPA Registration, Sterility | 0% import duty, domestic production common |
| πͺπΊ European Union | 3006.10.10 |
0% | CE Mark (MDR), ISO 13485, Sterility | Free trade within EU, strict MDR compliance |
| π¬π§ United Kingdom | 3006.10.10 |
0% | UKCA Mark, Sterility | Post-Brexit, UKCA required |
| π―π΅ Japan | 3006.10.10 |
0% | PMDA Approval, Sterility | 0% tariff, stringent approval process |
π Conclusion:
- Global Consensus: Sterile surgical sutures are typically 0% tariff worldwide.
- Regulatory Hurdle: The main barrier is FDA/CE/NMPA approval, not tariffs.
- US Advantage: No additional 301/IEEPA surcharges make this item highly competitive for import into the US.
π VI. Common Errors & Pitfall Guide (Lessons Learned)
β Error 1: Declaring non-sterile sutures as sterile surgical
π Consequence: FDA rejection, return/destruction, fines.
β Error 2: Using wrong HS code (e.g., 5401 for textile thread)
π Consequence: 5-10% tariff applied + FDA hold for missing medical clearance.
β Error 3: Omitting sterility certificates
π Consequence: Customs detention, costly re-testing or destruction.
β Error 4: Not filing FDA Prior Notice
π Consequence: Cargo denied entry, shipment delayed indefinitely.
β Correct Practice:
"Sterile Surgical Absorbable Suture, Gut/Polyglactin, 0 Gauge, 45cm, Pack of 10, 510(k) Number K123456, Lot# ABC, Exp. 2027, FDA Prior Notice Filed, HS 3006.10.01.00"
π― VII. Conclusion: Precision Declaration, Risk-Free Clearance, Cost Savings!
π― Remember the Mnemonic:
πΉ "Sterile + Surgical = 3006.10.01.00 | 0% Tariff | 100% FDA Compliance!"
πΉ "Wrong Code = Wrong Tariff + FDA Rejection = Total Loss!"
π Pro Tip:
- Ensure FDA 510(k) clearance is obtained before shipping.
- File FDA Prior Notice via BDCS system at least 8 hours before arrival (vessel) or 4 hours (air).
- Keep sterility certificates and lot traceability records for at least 2 years post-expiry.
π£ Immediate Action Required:
π Engage a FDA-registered customs broker
π¦ Prepare sterility certificates + 510(k) numbers
π Achieve zero-tariff, hassle-free clearance into the US market!
β¨ Professional Customs Clearance Starts with Accurate Classification!
πΌ Your every cent saved is meticulously calculated!
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About HS Code Classification
The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.
Each HS code follows a hierarchical structure:
- Chapter (2 digits) β Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) β More specific grouping within the chapter
- Subheading (6 digits) β Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) β Country-specific extensions for further classification, such as US HTSUS 10-digit codes
Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.
When importing from CN to US, the applicable tariff rates may include:
- Most-Favored-Nation (MFN) rate β The standard duty rate applied to WTO members
- General rate β Applied to countries without trade agreements
- Trade remedy duties β Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties
The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.