Per CDC required guidelines and disclosure, these products are not guaranteed to
be safe or effective for the prevention of COVID-19.
We are the only company who we are aware of that will guarantee the authenticity and quality of our surgical
masks because we manufacturer them in our own factory here in North America.
Production at our new facility begins early May 2020.
Please see our product page regarding respirators.N95 / Disposable FDA & CE Certified Masks
IMPORTING AND EXPORTING MEDICAL PRODUCTS UNDER AN EUA
Although an EUA is not an FDA-approval, a medical product authorized for emergency use under an EUA may be introduced into interstate commerce during the effective period of the EUA declaration, and as such, contingent upon compliance with the terms and conditions of the authorization, may be legally imported and exported under section 801 of the FD&C Act (21 U.S.C. 381). The letter of authorization should serve as appropriate documentation or certification that the product may be legally imported or exported.
- Emergency Use Authorizations (EUAs)
- Emergency Use Instructions (EUI)
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Filtering Facepiece Respirator (FFR)
- Medical Countermeasure (MCM)
- Public Readiness and Emergency Preparedness (PREP) Act
- Strategic National Stockpile (SNS)
Masks being produced by our partner firm here in North America.
We are manufacturing standard face masks and awaiting FDA approval to upgrade to surgical grade.