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hypoallergenic rubber gloves

CN β†’ US
HS Code Tariff Rate Origin Destination Doc
4015121010 110.0% CN US Official Doc
4015121020 110.0% CN US Official Doc

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🧀 Hypoallergenic Rubber Gloves (Medical/Surgical Use)


🌐 HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional-Level Compliance Strategy
πŸ“Œ I. Product Definition & Classification: Do You Really Understand "Hypoallergenic Rubber Gloves"?

Hypoallergenic rubber gloves are specialized protective gear designed for medical, surgical, dental, or veterinary professionals who have sensitivities to natural rubber latex. In international trade, the classification depends heavily on the specific purpose and material composition.

However, for HS Code classification purposes, the key distinction is often between: 1. General Medical Gloves: Used for hygiene, isolation, or general patient care. 2. Surgical Gloves: Designed for sterile surgical procedures, offering higher precision, fit, and sterility standards.

⚠️ Critical Distinction Point:
- If the gloves are intended for general medical use (examination, isolation, hygiene) β†’ Classified under 4015.12.10.10
- If the gloves are intended specifically for surgical procedures (sterile, high-precision fit) β†’ Classified under 4015.12.10.20
- Note: "Hypoallergenic" usually implies latex-free (nitrile, neoprene, or vinyl) or low-protein latex, but the HS Code structure for Chapter 40 (Rubber Articles) primarily categorizes by use (Medical/Surgical) rather than material composition, unless the material is "hard rubber" (which these are not). Both codes fall under "Vulcanized rubber other than hard rubber."


πŸ“¦ II. HS Code Classification Details (2026 Latest Tariff Authority Comparison)

HS Code Product Description Application Scenario Classification Basis
4015.12.10.10 Medical gloves, mittens, and mitts (General Medical Purpose) General examination, isolation, hygiene, dental procedures (non-surgical) "Of a kind used for medical or surgical purposes" (General Medical)
4015.12.10.20 Surgical gloves, mittens, and mitts (Surgical Purpose) Sterile surgical operations, high-precision medical interventions "Of a kind used for medical or surgical purposes" (Specifically Surgical)

πŸ” Key Reminder:
- The term "Hypoallergenic" does not change the HS Code category. It is a marketing or functional descriptor. The customs authority classifies based on the intended use (Medical vs. Surgical). - Both codes belong to Chapter 40 (Articles of Rubber), heading 4015 (Articles of apparel and clothing accessories, of vulcanized rubber other than hard rubber). - Subheading 4015.12 covers "Of a kind used for medical, surgical, dental or veterinary purposes." - The final digits (.10.10 vs .10.20) distinguish between General Medical and Surgical use.


πŸ’° III. 2026 Latest Tariff Rate Breakdown (Including Surtaxes & Policy Add-ons)

βœ… Applicable Country: United States (US)
βœ… Origin: China (CN)
βœ… Effective Date: From November 10, 2025 (including subsequent imports)

🎯 1. 4015.12.10.10 β€”β€” General Medical Gloves (Hypoallergenic/Non-Surgical)

Item Content
Base Tariff Rate 0.0% (ad valorem)
Section 301 Surtax +100.0% (100% additional duty)
Total Tax Rate 100.0%
Tax Calculation CIF Value Γ— 100%
De Minimis Exemption ❌ Not Applicable (Denied de minimis)
Legal Basis Path Section 301: 4015.12.10.10 β†’ 100% Surtax

πŸ“Œ Explanation:
- Although the base tariff is 0%, these goods are subject to a 100% additional tariff under the Section 301 trade action against China. - This is a prohibitive tariff level, effectively doubling the cost of goods. - No exemption is available for de minimis shipments (value under $800) for these specific HS codes from China.


🎯 2. 4015.12.10.20 β€”β€” Surgical Gloves (Hypoallergenic/Sterile)

Item Content
Base Tariff Rate 0.0% (ad valorem)
Section 301 Surtax +100.0% (100% additional duty)
Total Tax Rate 100.0%
Tax Calculation CIF Value Γ— 100%
De Minimis Exemption ❌ Not Applicable (Denied de minimis)
Legal Basis Path Section 301: 4015.12.10.20 β†’ 100% Surtax

πŸ“Œ Note:
- Identical tax treatment to general medical gloves. - Despite the higher quality and stricter standards of surgical gloves, the tariff rate is the same (100%). - Total cost impact: For every $10,000 CIF value, you pay $10,000 in duties.


πŸ› οΈ IV. Customs Clearance Operational Advice (Practical Pitfall Avoidance Guide)

βœ… 1. Documentation Checklist (Missing Any Item = Delay/Rejection)

Document Required? Explanation
βœ… Product Specification Sheet βœ”οΈ Must specify: Material (Nitrile/Latex/Vinyl), Sterility Level (Sterile/Non-Sterile), Intended Use (Surgical/Examination), Size, Powder-Free status.
βœ… FDA Registration Letter βœ”οΈ Medical gloves are Class I or II devices. Proof of FDA listing is often required for entry.
βœ… Certificate of Free Sale βœ”οΈ Issued by the country of origin, confirming the product is legally sold there.
βœ… Statement of Compliance βœ”οΈ Explicitly state: "Hypoallergenic, Latex-Free (if applicable), For Medical/Surgical Use."
βœ… Commercial Invoice βœ”οΈ Must clearly describe the goods as "Medical Rubber Gloves" or "Surgical Rubber Gloves." Avoid vague terms like "Rubber Accessories."
βœ… Bill of Lading/Air Waybill βœ”οΈ Standard shipping document.

βœ… 2. Declaration Tips (Key Mantra)

πŸ”₯ β€œSpecify Use, Not Just Material: Medical vs. Surgical Determines the Code, But Both Cost 100%!”

Scenario Correct Declaration Wrong Practice
Hypoallergenic Nitrile Gloves for Examination HS: 4015.12.10.10
Description: "Medical Gloves, Hypoallergenic, Nitrile"
Misclassifying as "Household Gloves" (HS 4015.90) β†’ Risk of penalty
Sterile Hypoallergenic Surgical Gloves HS: 4015.12.10.20
Description: "Surgical Gloves, Sterile, Hypoallergenic"
Under-declaring value β†’ Seizure & Fines
Generic Rubber Gloves for Cleaning HS: 4015.90.90.00 (Different Category) Using Medical HS Code for non-medical goods β†’ False Declaration

πŸ“Œ Warning:
- Do NOT try to misclassify medical gloves as "household" or "industrial" rubber gloves to avoid tariffs. Customs has strict criteria for "Medical/Surgical" use, and if caught, penalties are severe. - The 100% tariff is unavoidable for China-origin medical/surgical rubber gloves. Focus on accurate declaration to prevent delays.


βœ… 3. Special Situation Handling

Situation Handling Advice
Latex vs. Latex-Free Both fall under the same HS Codes if used for medical purposes. "Hypoallergenic" is a product feature, not a classification factor.
Sterile vs. Non-Sterile Sterile gloves are typically Surgical (...10.20). Non-sterile may be Medical (...10.10) or Surgical depending on manufacturer claim. Check product labeling.
Origin Substitution If shipped from Vietnam, India, or Thailand, the 100% Section 301 surtax may not apply. Ensure Certificate of Origin is valid and production occurred in the third country.
De Minimis Shipments ❌ Do Not Use for these HS Codes. The $800 exemption does not apply to medical gloves from China under current enforcement.

🌍 V. Global Market Clearance Comparison (2026 Latest)

Country/Region Recommended HS Code Tariff (China Origin) Certification Requirements Notes
πŸ‡ΊπŸ‡Έ USA 4015.12.10.10 / .20 100% (Base 0% + 100% Surtax) FDA 510(k) or Exemption Prohibitive tariff. High risk of audit.
πŸ‡¨πŸ‡³ China 4015.12.10.10 / .20 0% - 5% NMPA Registration No surtax.
πŸ‡ͺπŸ‡Ί EU 4015.19.80 / 4015.19.90 0% - 4.5% CE Mark + MDR No Section 301 equivalent.
πŸ‡―πŸ‡΅ Japan 4015.19.000 0% - 4.5% PMDA Notification Competitive rate.

πŸ“Œ Conclusion:
- The USA is the only major market with a 100% tariff on these specific medical rubber gloves from China. - Supply Chain Strategy: For US market, consider sourcing from non-China origins (e.g., India, Vietnam, Malaysia) to avoid the 100% surtax. - Domestic/Other Markets: Tariffs are significantly lower.


πŸ“Œ VI. Common Mistakes & Pitfall Guide (Lessons Learned)

❌ Mistake 1: Declaring "Hypoallergenic Gloves" without specifying "Medical/Surgical"
πŸ‘‰ Consequence: Customs may classify under general rubber goods (lower base rate) but audit and reclassify, leading to back-taxes + penalties.

❌ Mistake 2: Assuming "Latex-Free" means lower tariff
πŸ‘‰ Consequence: False. Nitrile and Vinyl medical gloves are still Class 4015.12. Tariff is 100%.

❌ Mistake 3: Using De Minimis for small shipments
πŸ‘‰ Consequence: Seizure. CBP explicitly denies de minimis for medical gloves from China.

❌ Mistake 4: Mixing Surgical and Non-Sterile Gloves in One Line Item
πŸ‘‰ Consequence: Customs Delay. Differentiate in the invoice. If mixed, declare separately or face queries.

βœ… Correct Approach:

"Surgical Gloves, Sterile, Hypoallergenic, Nitrile, Box of 100, Model XYZ, FDA Listed, Origin: China"


🎯 VII. Conclusion: Professional Declaration Saves Time, But Not Money!

🎯 Remember the Mantra:

πŸ”Ή "Medical Gloves, China Origin, 100% Tariff No Matter What!"
πŸ”Ή "Accurate Code is Critical to Avoid Penalties, But Tariff is Fixed at 100%."


πŸ“Œ Pro Tip:
If you are importing Hypoallergenic Rubber Gloves into the US from China, budget for the 100% duty.
Cost-Saving Strategy:
- Option A: Source from India, Vietnam, or Thailand (Tariff ~0-5%).
- Option B: Check if your product qualifies for any Exclusions (rare for medical gloves, but verify Section 301 Exclusion List).
- Option C: Use DDP (Delivered Duty Paid) terms with a freight forwarder who specializes in high-tariff goods to streamline customs brokerage.


πŸ“£ Immediate Action:

πŸ“ž Contact a Licensed Customs Broker to pre-verify your HS Code.
πŸ“„ Ensure FDA Registration is Up-to-Date.
πŸš€ Optimize Supply Chain to Avoid China Origin if Possible.


✨ Professional Clearance Starts with Accurate Classification!
πŸ’Ό Your Cost Efficiency Depends on Navigating the 100% Tariff Wall!

Customer Reviews

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.