DediCare produces 3 ply surgical masks and N95 masks.  All DediCare’s masks are made in the USA and produced at our production facility in Louisville, KY.

Not currently, however, we are evaluating other PPE products to produce. In the meantime, we can and have sourced different PPE products for customers. Please inquire at info@dedicaremed.com.

Yes, DediCare 3 ply surgical masks and N95 respirators meet the highest level in performance testing required by the FDA.  Specifically, the 3 ply surgical masks meet ASTM 2100-19 Level 3 and the N95 respirator meet 42 CFR 84 (FFR 2).  Please contact us at info@dedicaremed.com if you would like a copy of the test reports.

FDA EUA No. 210558 was granted on October 28, 2021, for DediCare’s 3 ply Surgical Masks.  The approval is listed on the FDA’s website at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#surgicalmasks.  DediCare has applied for FDA 510(k) approval for our 3 ply surgical masks and NIOSH approval for our N95 masks.  However, DediCare cannot guarantee if we will receive the certifications and if we do, the date on which the approval will be received.

You can purchase DediCare’s 3 ply surgical masks on Amazon using the link below or email us at info@dedicaremed.com and we can discuss your masks needs, including non-certified N95 masks.

https://www.amazon.com/dp/B09KFF2BJZ?ref=myi_title_dp

Discard the mask if it torn or there is any damage. 

No.  All DediCare’s masks are single use ONLY.  Discard after each use. 

We can ship internationally, please contact us at info@dedicaremed.com for all international inquiries.

Please contact us at info@dedicaremed.com.

Per the FDA’s website: Face masks, surgical masks and respirators all cover a wearer’s nose and mouth, but they differ in the several aspects.

• Face masks: A mask, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks that are not intended for a medical purpose are not considered medical devices. Face masks may be used by the general public and health care personnel as source control in accordance with CDC recommendations on Interim Infection Prevention and Control.
• Surgical masks: A mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks intended for medical purposes are considered medical devices. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests. Surgical masks are also tested for biocompatibility and are considered personal protective equipment (PPE). While surgical masks may be effective in blocking splashes and large-particle droplets, they do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face. Surgical masks are not respiratory protective devices (unlike respirators).
• Respirators, known as filtering facepiece respirators (FFRs), including N95s and surgical N95s, filter at least 95 percent of airborne particles. They are PPE that tightly fit the face and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic airborne particles in a health care setting. They provide a higher level of protection against viruses and bacteria when properly fit-tested.