Surgical Tie Masks

Yes, there are three unique levels of protection with ASTM-rated medical masks. Level 1 masks have the lowest barrier of protection, while Level 3 masks have the highest barrier of protection. For greater clarity on the differences, refer to the information in the charts below:

No. Nanoform Graphene is not added to PRIMED raw materials, used as a coating or otherwise employed in any form nor has it ever been used by PRIMED.

‍

Generally, there are three things you should look for to ensure your mask fits correctly:

1. The metal nose piece is at the top.
2. The pleats typically fall downwards and away from the nose (a “waterfall” pleat*).
3. The white, or smoothest side, is on the inside against the wearer’s skin; the color always faces out.
4. The wearer’s nose and mouth are covered by the face mask.

The filtration efficiency and protective ability of a face mask is compromised when the mask becomes wet, torn or dislodged. Generally speaking, the higher protection value of a mask the longer it will maintain filtration; however, there is no set rule for how long a mask should be worn as it depends on humidity levels, respiration rate, nasal discharge, talking, etc. A medical face mask should be worn for only one patient procedure or visit. If a mask gets wet or soiled it should be replaced.

ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. ASTM F2100 specifies the performance requirements for Medical Face Masks with five basic criteria:

1. BFE (Bacterial Filtration Efficiency): BFE measures how well the medical face mask filters out bacteria when challenged with a bacteria-containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. Aureus (average size 0.6-0.8 microns). In order to be called a medical/surgical mask, a minimum 95%filtration rate is required. Moderate and high protection masks must have bacterial filtration rates greater than 98%.

Some manufacturers use the Modified Greene & Vesley method to determine the BFE rating. This method is NOT recommended by ASTM for product comparison or evaluating consistency.

2. PFE (Particulate Filtration Efficiency): PFE measures how well a hospital mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. The higher the percentage, the better the mask filtration. Although testing is available using a particle size from 0.1 to 5.0microns, ASTM F2100 specifies that a particle size of 0.1 micron be used.

When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.

3. Fluid Resistance: Fluid resistance reflects the surgical mask’s ability to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray. ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg to qualify for low, medium, or high fluid resistance. These pressures correlate to blood pressure: 80 mm Hg = venous pressure (Level 1), 120 mm Hg = arterial pressure(Level 2), and 160 mm Hg (Level 3) correlates to potential high pressures that may occur during trauma, or surgeries that include high pressure irrigation such as orthopedic procedures.

4. Delta P (Pressure Differential): Delta P measures the airflow resistance of the medical mask and is an objective measure of breathability. The Delta P is measured in units of mm H2O/cm2 and the lower the value the more breathable the mask feels. The ASTM standard requires that masks have a Delta P of less than 6.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 5.0.

5. Flame Spread: As hospitals contain sources of oxygen, heat, and fuel the ASTM standards include testing for flame resistance. Testing dictates that all hospital masks must withstand exposure to a burning flame (within a specified distance) for three seconds. All PRIMED masks meet this requirement.

6. ISO Certification: In addition to the above tests, all medical face masks must be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user's skin.

‍

All individuals using medical face masks must be aware of the protective capabilities of the mask being worn. Healthcare workers should assess their risk of exposure to blood, body fluids, excretions and other potential hazards—and choose their mask accordingly.

A medical face mask is considered to be contaminated once it has been used, and should be discarded immediately. A mask should be removed by the edges or the ties rather than the front panel.

As part of Personal Protective Equipment (PPE), medical face masks with integrated visors are recommended to ensure compliance with eye protection. PPE includes all equipment and apparel that prevents potentially infectious material from contaminating clothing, skin, eyes, mouth, nose, or other mucous membranes.

‍

ASTM refers to the American Society of Testing and Materials American Society of Testing and Materials (ASTM). ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services—including those in healthcare.

‍

A mask is only as effective as its fit. There should be no gaps along the side, around the nose or under the chin that would allow air and droplets to bypass the filter medium. The mask should always be properly adjusted to fully cover both the mouth and nose. A well-fitting mask stays in place over the nose and cheeks and even a regular mask will prevent fogging of eyeglasses if it fits properly. Masks should not be worn underneath the nose or dangling around the neck – they should either be fully on, or disposed of.

‍