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 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.

1. Additional FDA information optional
2. Link for more details (https://www.fda.gov/media/135659/download)

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