PPE Importing (masks, gloves, hand sanitizers etc)- FDA / CBP Information

  • PPE Importing (masks, gloves, hand sanitizers etc)- FDA / CBP Information

    Below are some information collected through FDA / CBP updates in regards to PPE (Personal Protection Equipment) Importation. Sources: Lisaragan CB

     

    Masks
    6307.90.9889 @ 7%
    Exclusion code 9903.88.42
    • Masks for industry / non-medical use. We need confirmation in writing of end use. If confirmed for one of these reasons – disclaim FDA.
    • Disposable masks for medical / surgical (prevention of illness or COVID is medical) – this will be the majority of masks imported.
    • Intended use code 081.006
    • FDA product code Q-KR or some will be K-HA (we can look up the product on FDA website with manufacturer registration number or full name- link following: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm)
    • FDA has advised that reporting FDA registration number (manufacturer and importer) and device listing is optional. However, we believe that it is in the best interest of the importer to provide as much information FDA information as possible.
    • Respirator style masks – N95 / KN95 / ETC.
    • If the mask is N95 AND NIOSH approved it is subject to intended use code 940.00 – EUA.
    • FDA has advised that reporting FDA registration number (manufacturer and importer) and device listing is optional. However, we believe that it is in the best interest of the importer to provide as much information FDA information as possible.
    • If the mask is a KN95 and meets CDC requirements (test report or other proof provided) then FDA will defer to CDC guidelines – intended use code 940.00. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
    • FDA has advised that reporting FDA registration number (manufacturer and importer) and device listing is optional. However, we believe that it is in the best interest of the importer to provide as much information FDA information as possible.
    • If the respirator style mask does not meet either two criteria above – FDA intended use code will be 081.001.
    • Requires FDA registration from manufacturer, importer, and device listing number.
    • FDA product code: N-ZJ or M-SH (we can look up the product on FDA website with manufacturer registration number or full name- link following: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm)
    • If the origin of the mask is other than China, please reach out for further guidance.
    Disposable Coveralls
    Isolation Gowns
    Disposable Medical Wear
    Protective Suit
                   6210.00.5000 @ DUTY FREE
                   9903.88.39 – EXCLUSION
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Safety Goggles / Glasses
                   9004.90.0000 @ 2.5%
                   9903.88.42 – EXCLUSION
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Hand Sanitizers (alcohol based)
    3824.99.9297 @ 5% + 25%
                                  a. Requires FDA registration from manufacturer.
                                  b. Drug listing from manufacturer (NDC)
    Face Shield
                   3926.20.9050 @ 5%
                   9903.88.41 – EXCLUSION
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Gloves (nitrile, latex)
                   4015.19.0550 @ DUTY FREE
                   9903.88.39 – EXCLUSION
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Gloves (PVC, vinyl)
                   3926.20.1010 @ DUTY FREE
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Thermometer
                   9025.19.8040 @ DUTY FREE
                   9903.88.12 – EXCLUSION (only under $11 each)
                   FDA Intended use code – 081.001
                                   a. Requires FDA registration from manufacturer.
                                  b. Device listing from manufacturer.
                                   c. FDA registration from the importer.
    Shoe cover / hair cover or cap
                   6307.90.9889 @ 7%
                   9903.88.42 – EXCLUSION
                                   a. FDA not required.
    Diagnostic test kit (COVID test)
                   3822.00.5000 @ DUTY FREE
                   FDA Intended use code – 081.006
    1. Additional FDA information optional
    2. Link for more details (https://www.fda.gov/media/135659/download)
    Ventilator
                   9019.20.0000 @ DUTY FREE
                   FDA Intended use code – 081.006
    1. Additional FDA information optional
    2. Link for more details (https://www.fda.gov/media/136318/download)

     

    For more details in shipping, Customs and FDA, please contact us at sales@amoyline.com

    Amoy International LLC

    Tel: 626-855-3077

    Leave a comment

    Required fields are marked *