HS Code for Nitrile Glove: 4015.12 vs 4015.19 by Powder and Use
Disposable nitrile gloves classify into HTS 4015.12 (surgical gloves) or 4015.19 (other gloves, including exam grade). Powder-free vs powdered split. Section 301 25 percent on Chinese origin. Malaysian and Thai gloves are major sources. FDA 510(k) required for medical-grade.
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Open calculatorHS Code for Nitrile Glove: 4015.12 vs 4015.19 by Powder and Use
Disposable nitrile gloves are one of the highest-volume PPE imports in the US, with several billion units consumed annually. Malaysia and Thailand together supply over 75 percent of US imports by volume. The 2026 duty stack varies materially between Chinese (heaviest), Malaysian (clean), and other origins.
This guide covers the HTS 4015 classification by use and powder status, the duty stack by origin, the FDA medical-device framework, and worked examples for typical procurement.
Heading 4015 structure
HTS 4015 covers articles of apparel and clothing accessories (including gloves, mittens, and mitts) of vulcanized rubber other than hard rubber. Subheadings:
- 4015.11: Surgical gloves (of vulcanized rubber).
- 4015.19: Other gloves, mittens, mitts.
- 4015.90: Other articles of vulcanized rubber.
Statistical annotations within 4015.19 split by:
- Material: nitrile, latex (natural rubber), vinyl, neoprene.
- Powder: powdered or powder-free.
- Application: medical exam grade, industrial.
For disposable nitrile gloves (the dominant category):
- 4015.19.05: nitrile, exam grade, powder-free.
- 4015.19.10: nitrile, exam grade, powdered.
- 4015.12: surgical nitrile gloves (sterile).
Worked example: Malaysian nitrile gloves
500,000 USD of HTS 4015.19.05 (powder-free nitrile exam) from Top Glove Malaysia.
| Charge | Rate | Base | Amount (USD) |
|---|---|---|---|
| MFN duty | 0 percent | 500,000 | 0 |
| Section 122 | 10 percent | 500,000 | 50,000 |
| MPF | 0.3464 percent | 500,000 | 614.35 (capped) |
| HMF | 0.125 percent | 500,000 | 625 |
| Total | 51,239.35 |
Effective rate 5.2 percent. Malaysia is the largest source of nitrile gloves to the US and the duty stack is clean.
Worked example: Thai nitrile gloves
300,000 USD of HTS 4015.19.05 from Sri Trang Thailand.
| Charge | Rate | Base | Amount (USD) |
|---|---|---|---|
| MFN duty | 0 percent | 300,000 | 0 |
| Section 122 | 10 percent | 300,000 | 30,000 |
| MPF | 0.3464 percent | 300,000 | 614.35 (capped) |
| HMF | 0.125 percent | 300,000 | 375 |
| Total | 30,989.35 |
Effective rate 5.3 percent. Thai nitrile gloves are essentially at parity with Malaysian on duty.
Worked example: Chinese nitrile gloves
200,000 USD of HTS 4015.19.05 from a Chinese producer. Subject to legacy AD A-570-XXX (verify current order status, post-2024 review status).
| Charge | Rate | Base | Amount (USD) |
|---|---|---|---|
| MFN duty | 0 percent | 200,000 | 0 |
| Section 301 List 4A | 7.5 percent | 200,000 | 15,000 |
| Section 122 | 10 percent | 200,000 | 20,000 |
| AD (if active, country-wide ~84 percent historical) | 84 percent | 200,000 | 168,000 |
| MPF | capped | 200,000 | 614.35 |
| HMF | 0.125 percent | 200,000 | 250 |
| Total | 203,864.35 |
Effective rate 109.0 percent. (if AD is active). Chinese nitrile gloves are essentially non-importable when the AD is in force.
Worked example: Vietnamese nitrile gloves
200,000 USD of HTS 4015.19.05 from Vietnam.
| Charge | Rate | Base | Amount (USD) |
|---|---|---|---|
| MFN duty | 0 percent | 200,000 | 0 |
| Section 122 | 10 percent | 200,000 | 20,000 |
| MPF | 0.3464 percent | 200,000 | 614.35 (capped) |
| HMF | 0.125 percent | 200,000 | 250 |
| Total | 20,864.35 |
Effective rate 14.4 percent. Vietnamese nitrile gloves are about 9 percentage points more expensive landed than Malaysian or Thai due to the Vietnam Section 122 rate. Quality and reliability matter more than the 9 point gap for healthcare buyers.
FDA framework
Exam gloves (4015.19 nitrile, medical use):
- FDA Class I device, 510(k) exempt for most products.
- Must comply with 21 CFR 880.6250 (patient examination gloves).
- Producer must have FDA establishment registration.
Surgical gloves (4015.12):
- FDA Class II device, 510(k) clearance required.
- Sterility testing per USP <71>.
- Higher quality control standards.
Industrial gloves (4015.19 chemical-resistance use):
- Not FDA medical devices.
- Comply with OSHA 29 CFR 1910.138 and ANSI/ISEA 105 for industrial hand protection.
Imports of medical-grade gloves without FDA establishment registration or 510(k) (where required) are detained.
Documentation that supports the classification
- Commercial invoice with HTS 10-digit, country of origin, material (nitrile), use (exam vs surgical vs industrial), powder status.
- Packing list with units per carton.
- FDA establishment registration number for the producer (medical-grade).
- For surgical gloves: FDA 510(k) number.
- For industrial gloves: ANSI/ISEA 105 conformity statement.
Active US ADCVD orders on gloves
The historical AD order against Chinese disposable gloves (A-570-XXX series) has been the subject of multiple sunset reviews. Always verify current order status at the Commerce database before importing.
Malaysian, Thai, Indonesian, Vietnamese gloves: no active orders as of mid-2026.
Run your nitrile glove entry now
The LandedFees calculator handles 4015 by use and powder status, the country-specific Section 122 stack, the active ADCVD orders, the FDA Class I or II flag, and the producer registration requirement check.
Calculate a nitrile glove entry
Section 122 status as of June 20 2026
The May 7 2026 Court of International Trade ruling in Oregon v. United States (consolidated with Burlap and Barrel v. United States) struck down the Section 122 proclamation. The Federal Circuit issued an administrative stay on May 12 2026, so CBP is still collecting the duty pending appeal. Importers paying now should preserve protest rights and refund claims in case the government loses on the merits. The underlying Section 122 authority sunsets July 24 2026 under the statutory 150-day ceiling, regardless of the appeal outcome, unless Congress extends or a fresh proclamation restarts the clock.
Citations
- USITC Harmonized Tariff Schedule heading 4015: https://hts.usitc.gov/?query=4015
- USTR Section 301 List 4A
- Commerce ADCVD orders: https://access.trade.gov
- FDA 21 CFR 880.6250 Patient examination gloves
- FDA establishment registration
- OSHA 29 CFR 1910.138 hand protection
Frequently asked questions
What HTS covers exam-grade nitrile gloves?
HTS 4015.19 covers other gloves (not surgical). Statistical annotations split by material (nitrile vs latex vs vinyl) and powder status (powdered vs powder-free). Exam-grade nitrile sits in 4015.19. Surgical-grade nitrile (sterile, individually packaged) sits in 4015.12.
Are nitrile gloves on Section 301?
Yes for Chinese origin. HTS 4015.19 is on Section 301 List 4A at 7.5 percent. Section 122 (10 percent) stacks. Total Chinese-origin nitrile glove stack is approximately 30 percent.
Why is Malaysia the largest source?
Top Glove, Hartalega, Kossan, Supermax (all Malaysian) together produce 60+ percent of world nitrile glove supply. Concentrated capacity, low labor cost, established export infrastructure. Thailand (Sri Trang, Latexx) is the second-largest source.
Does FDA approval apply to all nitrile gloves?
Medical-use nitrile gloves are FDA Class I devices (exam-grade) or Class II (surgical-grade) requiring 510(k) clearance. Industrial-use gloves (chemical resistance, food handling) have different regulatory paths but not FDA medical device clearance.
Are there active ADCVD orders on gloves?
Yes. AD on certain disposable gloves from China (older order, country-wide rate around 84 percent). Active reviews on Malaysian and Thai disposable gloves periodically. Verify against the Commerce database before importing.
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