HS Code for Surgical Mask: 6307.90 vs 9020.00 by Filtration Level

The PPE supply chain went through a once-in-a-century stress test during COVID-19 and re-emerged in 2026 as a permanently larger US import category. Chinese suppliers still dominate the disposable surgical mask volume globally. Vietnamese, Indonesian, Malaysian, and Mexican mask production has grown as a hedge. The 2026 duty stack differs materially between surgical masks (chapter 63) and N95 respirators (chapter 90).

This guide covers the HTS classification, the FDA framework, the active Section 301 treatment, and worked examples by origin.

Heading 6307 (made-up textile articles) vs heading 9020 (breathing appliances)

The line between 6307 and 9020 is drawn by:

1. Filtration efficiency: Surgical masks have lower-rated filtration (typically 95 percent BFE for ASTM Level 3 but uncontrolled fit, no rated air seal). N95 respirators have NIOSH-rated 95 percent NaCl filtration with fitted seal.

2. Fit specification: Surgical masks loose-fit around the face. N95 respirators must seal against the face to prevent bypass leakage.

3. Pressure handling: 9020 covers "breathing appliances" which is a pressure-handling category. Respirators with valves or filtration housings that handle inhalation/exhalation pressure differential are in 9020.

A flat 3-ply disposable mask: 6307.90. An N95 cup-shaped molded respirator with NIOSH cert: 9020.00.

Worked example: Chinese disposable surgical masks

100,000 USD of HTS 6307.90.98 disposable 3-ply masks from China.

Effective rate 31.8 percent. The COVID-era 301 exclusion expired; current List 4A rate applies.

Worked example: Vietnamese disposable masks

100,000 USD of HTS 6307.90.98 from Vietnam.

Effective rate 21.3 percent. Vietnamese masks are about 10 percentage points cheaper landed than Chinese equivalents.

Worked example: Chinese N95 respirators

200,000 USD of HTS 9020.00.60 N95 respirators from China.

Effective rate 42.3 percent. The N95 classification (9020 vs 6307) increases the Section 301 layer from 7.5 percent to 25 percent because List 1 covers more 9020 lines than List 4A covers 6307 lines.

Worked example: Korean N95-equivalent (KF94)

200,000 USD of HTS 9020.00.60 from Korean producer (KF94 grade, FDA 510(k) cleared).

Effective rate 10.3 percent. KORUS waives the MFN duty but does NOT carve out Section 122. Korean N95-equivalents still pay the 10 percent surcharge. The KORUS advantage on this line is the absence of Section 301 (China-only), not a Section 122 carve-out.

FDA framework

For surgical masks (6307.90):

• Medical use claims: FDA Class II device. 510(k) premarket notification required. Performance testing per ASTM F2100 (filtration, fluid resistance, breathability).
• Non-medical use (no medical claims): No FDA clearance required.

For N95 respirators (9020.00):

• Healthcare use: Both FDA 510(k) and NIOSH 42 CFR 84 certification required.
• Occupational use (industrial): NIOSH certification only.
• Foreign-made respirators: NIOSH may grant certification under specific protocols. KN95 (China standard) is NOT NIOSH-certified by default unless the specific producer applied.

Imports lacking required FDA clearance are detained. The detention can be released if the importer reclassifies the product as non-medical and changes labeling, or if 510(k) is obtained.

Documentation CBP and FDA want

• Commercial invoice with HTS 10-digit, country of origin, intended use (medical vs non-medical).
• For medical-use masks: FDA 510(k) number on the entry.
• For respirators: NIOSH approval number (TC-84A-XXXX format) or FDA 510(k).
• For non-medical masks: labeling that does not claim medical / surgical / respiratory protection.
• Packing list.
• Bill of lading.

Specific labeling considerations

CBP scrutinizes mask packaging at entry. Claims that trigger FDA jurisdiction:

• "Medical use"
• "Surgical"
• "FDA approved" (also requires actual 510(k))
• "Hospital grade"
• "Respiratory protection"
• "N95" or "KN95" without NIOSH/FDA approval

Imports labeled with these claims without clearance get detained.

Run your mask entry now

The LandedFees calculator handles 6307 vs 9020 classification logic, the Section 301 layer by list, the Section 122 by country, the FDA clearance flag based on declared intended use, and the labeling compliance check.

Calculate a mask 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 6307: https://hts.usitc.gov/?query=6307
• USITC Harmonized Tariff Schedule heading 9020: https://hts.usitc.gov/?query=9020
• FDA Surgical Masks Guidance: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control
• NIOSH 42 CFR 84 Respirator Approval: https://www.cdc.gov/niosh/npptl/
• USTR Section 301 List 1 and List 4A
• ASTM F2100 standard for surgical masks