CMC-10 - 1000 Cnt.

Free shipping!  This is the perfect ASTM Level 1 mask for physician's waiting rooms, preliminary patient examinations, administrative staff, and general users. 

The CMC-10 mask has undergone third-party laboratory testing to provide fluid barrier protection and flammability resistance equivalent to an ASTM Level 1 mask per the FDA's underlying requirements. These surgical masks are designed to cover the user's mouth and nose and to provide a physical barrier to fluids and particulate materials.

They are single-use, disposable, flat, pleated, ear-loop-style masks for medical care personnel and general users made and marketed under the FDA's Emergency Use Authorization dated August 5, 2020. The mask is listed on Appendix A: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas 

The mask comes in light blue.

Other discounts available when quantities over 10,000 are ordered.  Send an email to info@ctmaskco.com.

Disclosure:

This product is a non-sterile, disposable, single use, ASTM Level 1 surgical mask. It is a flat, 3-layer, pleated, surgical mask with ear loops. 

These surgical masks are not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators. They are not intended to provide protection against pathogenic biological airborne particulates and are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure.

The CMC Surgical Mask 10 meets or exceeds the following ASTM F2100-19 performance requirements for a Level 1 surgical mask:

The CMC Surgical Mask 10 has not been FDA cleared or approved. This product is not manufactured in China and does not include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents.

The CMC Surgical Mask 10 is authorized by the FDA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

Intended Use of Product:

The CMC Surgical Mask 10 has been authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use in healthcare settings by health care personnel (HCP) as personal protective equipment (PPE) to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

Surgical masks are not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators. Surgical masks may be effective in blocking splashes and large particle droplets; however, because of the loose fit between the surface of the surgical mask and the user’s face, leakage can occur around the edge of the mask when the user inhales. Therefore, a surgical mask may not provide the user with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection. For this reason, surgical masks are not recommended for use in aerosol-generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure. In such clinical conditions, a filtering facepiece respirator (such as an N95 respirator) with a tight fit is recommended to provide a more reliable level of respiratory protection against pathogenic biologic airborne particulates. 

Body Contacting Materials:

The CMC Surgical Mask 10 is constructed with three layers of nonwoven polypropylene. Direct body contacting materials include polypropylene, spandex, and nylon. Indirect body contacting materials include polypropylene, iron wire coated with polyethylene embedded within the three layers.