Indiana Face Mask SM3 Surgical Mask Receives 510(k) clearance from the FDA [PRESS RELEASE]

Rensselaer, Indiana – [03/02/21]. ASTM Level 3 surgical masks manufactured by Indiana Face Mask recently received 510(k) clearance from the US Food and Drug Administration (FDA).


The IFM Surgical Mask Model SM3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

For the US market, Indiana Face Mask is now providing FDA cleared surgical masks meeting the Level 3 standard of the American Society of Testing and Materials (ASTM). The ASTM Level 3 surgical mask is for use in conditions where there is a high risk of fluid and spray of aerosol transmission, such as operating procedures.

Surgical masks by Indiana Face Mask were tested for performance in five areas: fluid resistance, differential pressure, particulate efficiency, bacterial filtration efficiency and flammability. Upon completion of testing, the surgical masks consistently met ASTM Level 3 criteria in all five performance test areas. Bacterial and particle filtration efficiency test results were greater than 99 percent.

“This was a great accomplishment for our team. It is a milestone that supports our commitment to continue manufacturing local. Meeting the ASTM Level 3 standard helps us in our goal to not only keep our healthcare workers safe, but also ensure they have a steady, reliable PPE supply so the shortages that happened at the beginning of the pandemic don’t happen again,” -Clayton Geyer.

The Rensselaer site of Indiana Face Mask began mask production in early 2020 in response to the COVID-19 pandemic. Working closely with local partners, Indiana Face Mask is also aiming to prevent future PPE supply shortages by establishing long-term face mask production for the US market. The site manufactures surgical masks and NIOSH N95 respirators.




Contacts for media inquiries:
Indiana Face Mask
Attn: Clayton Geyer
3300 W Clark St
Rensselaer, Indiana USA
clayton@ifmasks.com

Please send publication copies to this address.


About Indiana Face Mask

We are a Family Owned and Operated Business with a commitment to Quality, Comfort, Sanitation, and Customer Service!

In the past year, Indiana Face Mask has worked nonstop to provide the highest quality PPE to the American People, while also creating numerous jobs for the people of Indiana.

100% made in Rensselaer, Indiana USA!

 


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