MASKCORP AMERICA SPECIALIZES IN ALL LEVELS OF MASK AND RESPIRATOR TECHNOLOGY

made in usa

Our surgical masks and respirators are 100% made in the USA

We source all our textiles from local USA based textile mills and manufacture all our masks in Texas. This ensures our masks and respirators are made using quality materials while at the same time undergoing rigorous quality control inspections. At MaskCorp America, we do everything in our power to supply reliable and quality surgical masks and respirators.

MaskCorp America takes the extra steps to ensure you receive only the best surgical mask level 1, surgical mask level 2, surgical mask level 3, and N95 respirators.

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When it comes to cross-contamination prevention, we are the industry experts.

With over 20 years of experience in the manufacturing industry, we know a thing or two about quality. We cut no corners when it comes to the production of our mask styles or respirator styles.

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As the surgical mask and facepiece respirator experts, our website was built not only for us, but for you.

We want to make sure you have all the facts and knowledge to make informed decisions when looking for a surgical mask or respirator that fits your healthcare office or family needs.

you can trust us

At MaskCorp America, we care about quality and performance

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When we produce a mask or respirator, we take the necessary steps to ensure everything that leaves our facility meets the proper certification requirements.

WE’ve MET THE REQUIREMENTS

We provide three levels of surgical masks

Surgical face mask material performance is based on testing for bacterial filtration efficiency (ASTM F2101), differential pressure (EN 14683), sub-micron particulate filtration efficiency (ASTM F2299), resistance to penetration by synthetic blood (ASTM F1862), and flammability (16 CFR Part 1610).

A surgical mask is certified by the FDA through independent lab testing.

Once our levels of surgical mask styles have passed the testing stage, we submit a 510(K) to the FDA and get final approval. Each level has its own requirements as listed below.

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1

Surgical Mask

Level 1

Requirements
2

Surgical Mask

Level 2

Requirements
3

Surgical Mask

Level 3

Requirements
Fluid resistance 80mmHg 120mmHg 160mmHg
BFE ≥95% at 3 micron ≥98% at 3 micron ≥98% at 3 micron
PFE ≥95% at 0.1 micron ≥98% at 0.1 micron ≥98% at 0.1 micron
Delta P, mm H20/cm2 < 4.0 < 5.0 < 5.0
Standard EN14683 Rating Type II Standard EN14683 Rating Type IIR Standard EN14683 Rating Type IIR Standard
Standard specification for performance of materials used in medical face masks ASTM F2100-19 ASTM F2100-19 ASTM F2100-19
Standard specifications for medical face masks EN 14683:2019 EN 14683:2019 EN 14683:2019
BFE % ASTM F2101, EN 14683 ASTM F2101, EN 14683 ASTM F2101, EN 14683
PFE % ASTM F2299 ASTM F2299 ASTM F2299
Synthetic Blood ASTM ASTM F1862, ISO22609 ASTM F1862, ISO22609 ASTM F1862, ISO22609
Differential Pressure EN 14683 EN 14683 EN 14683
Flammability 16 CFR Part 1610 16 CFR Part 1610 16 CFR Part 1610

learn more about surgical mask certification testing

Click on the links below to learn more about the independent testing required by the FDA for a surgical mask.

There are two levels of respirators we provide

In the United States a respirator is certified by NIOSH

Each filtration rate of our respirators are independently tested following the below requirements. In the United States a respirator is certified by NIOSH (National Institute for Occupational Safety and Health). NIOSH is a division of the CDC (Centers for Disease Control and Prevention).

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NRC110C Sodium Chloride (NaCl)
  • The Sodium Chloride Aerosol Challenge test is able to determine filtration efficiency measurements up to 99.999%. In this procedure, the TSI® CERTITEST® Model 8130 Automated Filter Tester reservoir is filled with a 2% NaCl solution.* The sample is placed into the filter holder. Cone or molded masks and respirators are mounted to a test fixture and sealed into a cylinder filter holder to ensure that the mask is properly sealed. Samples are subjected to aerosolized NaCl. The concentration of NaCl is measured before and after impact with the sample. The amount of NaCl that passes through the sample is used to calculate the filtration efficiency of the sample. Respirators for NIOSH pre-qualification are required to be preconditioned at 85 ± 5% RH and 38 ± 2.5°C for 25 hours prior to assessing the filtration efficiency.
  • Tests are performed according to: 42 CFR Part 84 “Approval of Respiratory Protective Devices.”
NRC115C Dioctyl Phthalate (DOP)
  • The DOP aerosol test is a widely accepted method for evaluating particle penetration and air flow resistance properties of a variety of filtration materials (e.g., breathing system filters, NIOSH respirators and face masks). The procedure employs an aerosol of DOP using a TSI® CERTITEST® Model 8130 Automated Filter Tester. Test articles are challenged with particles of the most penetrating particle size range, 0.3 µm. Filtration efficiency measurements can be determined up to 99.999%. Samples can be tested at flow rates up to 90 liters per minute (LPM). The filtration requirement for HEPA filters is 99.97% at 0.3 µm using the DOP test.
NRC120C Inhalation and Exhalation
  • Tested according to 42 CFR Part 84

Learn more about respirator independent testing

Click on the links below to learn more about the independent testing required for a N95 respirator and N99 respirator.

an extra step to ensure our quality

We do everything we can to provide high quality masks and respirators

Beyond all the tests and certifications of our mask and respirator products, we have taken an extra step to ensure our quality management system meets national and international requirements.

MaskCorp America is currently in the process of becoming ISO 13485 certified. This means that our quality management system adheres to stringent protocols and we can track and trace final products from raw goods to final deliverables. When you order a mask or respirator from MaskCorp America, you can trust that we do everything possible to ensure our final deliverables are of the highest quality possible.

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