Personal Protective Equipment
We are leveraging our long-standing USA manufacturing lines to build American-made personal protective masks and gowns. The material we use provides a moderate to high level of protection and meets ANSI/AAMI PB70 Level 3 for critical zone areas liquid barrier protection and is ASTM F1671 tested for blood borne pathogen (viral) penetration.
Our Personal Protection face mask complies with the FDA’s Emergency Use Authorization for availability of face masks (April 18, 2020). They are authorized under the EUA when used by members of the general public, including health care providers in health care settings as personal protective equipment in accordance with CDC recommendations to prevent the spread of SARS-CoV-2.
Our Surgical Gown complies with FDA's emergency authorization under the March 2020 “EnforcementPolicy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) PublicHealth Emergency Guidance for Industry and Food and Drug Administration Staff.” This product has not been FDA cleared or approved.
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