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Now FDA 510(k) Cleared ASTM Level 3 Disposable Surgical Masks Available For Sale

 June 3, 2021: We are excited to announce that the FDA has cleared our ASTM Level 3 Disposable Surgical Masks using US sourced materials, to be released for sale.  For further information, please contact us through link below. 

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Current Domestic Promotions

Florida-based American Surgical Mask is offering a “New Way to Buy”. Save money, know what you are buying while doing your part to ensure that US manufactured PPE will thrive, and be secure from future disruptions.  Please see links below.

Case for Contract ManufacturingDental Office Buy Direct Program

President and Congress Close to Passing Laws Requiring Federal Funds Be Used To Buy US Manufactured PPE

The President in his February 24th Executive Order on “Supply Chain” committed to protecting domestic PPE manufacturing as a national security priority after the disaster of 2020 when our healthcare infrastructure was on the verge of collapse.  Both the President and Congress on a bipartisan level are now on the verge of passing sweeping new legislation that will require that all federal funds for PPE must be used to purchase US manufactured products.  What makes such an act possible is that since the beginning of 2020, US based entrepreneurs have established a domestic capability including surge capacity to eliminate our previous 90% dependence on imported products.

Establish Your US Made PPE Supply Chain NowLatest Legislative Updates (Bi-Monthly)

International Exports of PPE Open: Partner Now

The US government is now permitting exports of our surgical masks. To partner or establish trade in global markets, please see “Contact Us” page under “International”. 

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The question is not “if” another pandemic will occur, it is a question of “when”, “how serious” and “will we be better prepared next time?” In 2020, our healthcare system was on the brink of collapse due to the lack of domestically manufactured PPE.

Experts have warned that an upcoming pandemic could be 10 times worse and that humanity is not prepared for it. Leaders must learn the lesson that COVID-19 is giving us including predictions that a similar viral outbreak will likely occur every 20 years or so.

Volume Purchases & Contracts

Through our partnerships with other vetted AMMA (See Below) partners across the United States, we are collectively capable of meeting large scale orders of high quality masks of up to 500 million per month. Contact us for more information whether domestic or international. 

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As a founding member of the AMMA representing over 20 US manufacturers of  masks using domestically sourced materials. We are committed to preserving our domestic PPE manufacturing capability to protect our heathcare workers and our nation from a repeat of 2020 and the vulnerabilities it revealed. Act Now!

 

 

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Regulatory Compliance You Can Trust

Our medical procedural grade surgical masks have been tested to the highest standards per ASTM.  All of the masks we produce meet the medical procedural use requirements.

American manufactured product

FDA 510(k) Cleared ASTM Level 3 Masks

We manufacture in Tampa, Florida and are regulated by the FDA to ensure an uninterrupted supply of reliable quality masks for our medical facilities, staff and essential workers around the country. Our masks are manufactured using ASTM tested materials that provide the most protection for its user.

Photo_Fasther and Son with Disposable Surgical Masks

100% US Sourced Materials

Nearly 90% of domestic mask supplies and materials were sourced from overseas early in the pandemic. We are on the verge of having 100% of our mask materials sourced from US manufacturers, thus ensuring a secure supply chain that cannot be disrupted.

State of the Art Equipment

Our state-of-the-art ultrasonic welding technology provides a consistent, reliable product, assuring customers that consistent high-quality standards are met. Our integrated artificial intelligence (AI) based technology, with its high efficiency, allows us to produce masks at competitive prices.

© 2020 American Surgical Mask Co