CMC-10 - 500 Count

Vendor: Connecticut Mask Company
Regular price: $155.00
Regular price
Sale price: $155.00
Unit price: per

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

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.

Authorized by the FDA! Verify CMC's listing on the FDA's Website.

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

Test Standard	Characteristic	Level 1 Barrier
ASTM F2101	Bacterial efficiency, %	≥ 95
ASTM F2100 / EN 14683	Differential pressure, mmH₂0/cm²	< 4.0
ASTM F2299	Sub-micron particulate filtration efficiency at 0.1 micron, %	≥ 95
ASTM F1862	Resistance to penetration by synthetic blood, minimum mmHg	80
16 CFR Part 1610	Flame spread	Class 1

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.

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 a significant risk of infection through inhalation exposure.

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.

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 a 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. The direct body contacting materials include polypropylene, spandex, and nylon. The indirect body contacting materials include polypropylene, iron wire coated with polyethylene embedded within the three layers.