Why Omnimask

OmniMask is made with silicone—the gold standard for wearer comfort and skin protection—instead of cheap thermoplastics used in other masks.

Made from extra soft Shore 30A silicone—like nipples on baby bottles—OmniMask is noticeably more pliable and comfortable than masks made from Shore 50A thermoplastics.

Dual airflows +200% larger than 3M and valves with ultra-low cracking pressure reduce breathing resistance and improve air flow.

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

Microtextured inner surfaces help prevent the build up of moisture where the mask touches the lipids of the skin (i.e., the octupus-suction-cup effect of some masks).

To help prevent muscle fatigue and pressure points, OmniMask is under 4 oz. — plus a small amount for whichever filters you use. (For example, 3M filters add about one ounce.)

Silicone can be formulated for a specific softness represented by its target Shore A durometer rating—a standardized system for measuring the softness of rubbery materials. The higher the rating number, the harder the material.

We formulate the medical-grade silicone in OmniMask to a very soft Shore 30A rating. Through extensive testing, we found this value maximizes wearer comfort while preserving structural stability.

In contrast, all major-brand masks that we tested reported a semi-rigid Shore 50A-rating (akin to a pencil's pink eraser) due to their manufacture from more rigid oil-based thermoplastics. These masks tend to be stiffer and less conforming to the specific contours of a user's face, which negatively impacts both seal and comfort.

For comparison purposes, the following chart describes some common items and their Shore A ratings.

Shipping cost is based on weight. Just add products to your cart and use the Shipping Calculator to see the shipping price.

We want you to be 100% satisfied with your purchase. Items can be returned or exchanged within 30 days of delivery.

Shipping cost is based on weight. Just add products to your cart and use the Shipping Calculator to see the shipping price.

We want you to be 100% satisfied with your purchase. Items can be returned or exchanged within 30 days of delivery.

Shipping cost is based on weight. Just add products to your cart and use the Shipping Calculator to see the shipping price.

We want you to be 100% satisfied with your purchase. Items can be returned or exchanged within 30 days of delivery.

Shipping cost is based on weight. Just add products to your cart and use the Shipping Calculator to see the shipping price.

We want you to be 100% satisfied with your purchase. Items can be returned or exchanged within 30 days of delivery.

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, an alternative and lower cost material, peroxide-cured silicone 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 create 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.

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