Made from silicone—the gold standard for wearer comfort and skin protection—OmniMask is skin friendly and noticeably more comfortable than the majority of masks made from rubberized plastics.

CLICK HERE to Learn about OmniMask's SHORE 30A Softness Rating

One-way valves combined with airflows twice as large as other brands combine to make breathing easy again.

Dual Inlets mounted rearward draw fresh, cooling air across the cheeks with every breath - a change that produces more cooling than the inherently warmer "filter forward" placement in other masks.

Microtextured inner surfaces help prevent the build up of moisture and heat where the mask touches skin.

OmniMask is under 4 oz — the same as a deck of cards. 3M pancake-style filters add about 1 oz.

OmniMask utilizes FDA-rated silicone, which is the material of choice for medical, baby, and other sensitive applications due to its advantages in safety, non-toxicity, and comfort. As a premium material, silicone is more expensive to purchase and process than other options, also requiring high-precision equipment for shaping and vulcanization.

To reduce costs most mask makers replace silicone with Thermoplastic Elastomers (TPE), a class of materials used in products ranging from automotive parts to yoga mats. As it is an oil-based plastic, TPE tends to feel oily to the touch and less comfortable on skin than silicone.

The main body of OmniMask is made from platinum-cured silicone—the preferred material for medical, baby, and other high-purity applications due to the absence of post-curing byproducts.

In contrast, some other manufacturers use peroxide-cured silicone, a cheaper material that tends to generate volatile organic acids and other byproducts during the curing process. In addition to potential toxicological concerns, these and other post-curing impurities can lead to off-gassing and generate a hazy appearance and oily feel.

OmniMask utilizes only platinum-grade silicone manufactured by a reputable global supplier. Test articles from the manufacturer were evaluated by independent lab SGS with reference to ISO 10993 (Biological Evaluation of Medical Devices) with the following results:

• ISO 10993-5: 2009 - Test for in vitro cytotoxicity (Result: no cytotoxic potential)
• ISO 10993-10: 2010 - Test for irritation and skin sensitization (Result: no evidence of sensitization)
• ISO 10993-11: 2006 - Test for systemic toxicity (Result: nonpyrogenic)
• ISO 10993-12: 2012 - Sample preparation and reference materials

We publish the full set of independent test reports on our website.

Early in development, beta testers suggested an improvement — the use of latex-free materials in our headgear and check valves — so we gladly made this change, resulting in a completely latex-free design.

Through that process we realized the value of formally integrating customer feedback early and often into our designs and product roadmap. We find this level of listening helps us create better products that are more responsive to our customers' needs.

We use FDA-grade polycarbonate to form the optically clear face of OmniMask. Designed for use in medical products, this material meets the requirements of ISO 10993, which is the international standard for the Biological Evaluation of Medical Devices (comparable to GB/T 16886.1). The following are a list of the tests and results:

• ISO 10993-5: 2009 Test for in vitro cytotoxicity (Result: non-cytotoxic)
• ISO 10993-10: 2002 Test for irritation and skin sensitization (Result: 0% Sensitization Grade I)
• ISO 10993-11: 2006 Test for systemic toxicity (Result: meets requirements—no reactions greater than controls)
• ISO 10993-3: 2003 Test for genotoxicity, carcinogenicity and reproductive toxicity (Result: non-mutagenic in test species)

All independent test reports are published here.

ISO 13485 defines the Quality Management System requirements for the manufacture of medical products.

While meeting this standard is not required for mask manufacturing—or technically even for NIOSH approval—the silicone and polycarbonate portions of OmniMask are produced at facilities rated to this standard in order to help ensure the highest quality products.

Current NIOSH regulations interpret the federal statute on breathing protection to prevent the review or approval of any mask that utilizes filters from other manufacturers.

This means that despite the fit, comfort, clear face, and filter interoperability offered by OmniMask, NIOSH will not consider it for testing and approval.