LogiWorld is working closely with manufacturers, trade companies, medical suppliers, and laboratories on the sourcing of PPE material. Please reach out on how we can assist your import/export operation on all things PPE. We have compiled some important information on PPE masks for you to review below.
If the mask to be imported is “Industrial” with no mention on any of the labeling to show medical then we are able to import as normal and this commodity does not require FDA. The HTS for this type would be 9020.00.6000 2.5% (does not prompt for FDA).
If the masks imported are the regular face masks that are used in the hospital setting; this would require FDA and be under 6307.90.9889 7% (China Exclusion code 9903.8842) and will require FDA.
If the masks are the KN95 or 95 which are surgical/health masks they will require FDA and also be classifiable under 6307.90.9889 7% (China Exclusion code 9903.8842); please also note that the masks, if imported prior to the COVID19 Pandemic , will have a MSH# or a 510K#. If they do not have the MSH or 510K #s they will need to be registered with the FDA and need to email CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the text “Non-NIOSH-Approved Respirator” in the subject line and include: CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the text “Non-NIOSH-Approved Respirator” in the subject line and include:
A. General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any) in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region).
B. A copy of the product labeling.
C. Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available).
D. Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such.
E. Description of testing conducted on the device, including any standards met, such as liquid barrier protection, flammability, biocompatibility, and filtration performance, as appropriate
- Non-NIOSH Approved Respirator EUA FAQ
- N95 Respirators and Surgical Masks (Face Masks)
- Coronavirus Emergency Use Authorizations for Medical Devices
Comparing Surgical Masks and Surgical N95 Respirators
The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
A surgical mask is loose-fitting in nature. It’s purpose is to create a barrier between the mouth and nose to protect from any possible contaminants. This mask is also disposable. Most notably, the edges of the mask do not form a seal around the mouth and nose.
N95 respirators are designed to have a tight fit around the nose and mouth, built to efficiently filtering airborne contaminants. Surgical N95 Respirators form a tight seal around the mouth and nose and serve as a safe option for healthcare workers
Similarities Between Surgical Masks and N95 Respirators:
- Both are tested for fluid resistance, filtration efficiency, flammability and biocompatibility
- Neither should be reused or shared
Please contact our team should you need additional clarification or if you have additional questions about shipping surgical masks and N95 repirators. We are 24/7 for all of your PPE shipments.