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  • ASTM Surgical Mask Level 3 GIF
  • ASTM Surgical Mask Level 3 TaiBao
  • ASTM Surgical Face Mask Level 3 ASTM F2100-19

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ASTM Level 3 Masks

$34.99 / Box of 50 Level 3 Masks
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Flora's ASTM Level 3 surgical masks have received 510(k) approval from the FDA (#K202096) and are produced in the United States at an FDA registered production facility. They are made from three-layers of non-woven material and are comfortable to wear. We limit many of our products to buyers in specific, prefered groups to preserve necessary product for front-line & essential service workers. We can now sell ASTM Level 3 masks to dentists, orthodontists, caregivers / CRMAs, and other medical practices, as well as hospitals & government purchasing agents.


ASTM Level 3 Masks are recommended for use in areas with procedures in which moderate to high amounts of fluid, spray and/or aerosols are produced, such as complex oral surgery, crown preparation, implant placement, periodontal surgery, and more.

  • Approvals: FDA 510(k)
  • SIZES: One Size Fits All (Adult)

ASTM Level 1 Masks (In Stock)
  • Description
    American Society for Testing & Materials (ASTM)
    ASTM F2100-19 Test by TÜV Rheinland
    Level 3 Test Results
    Fluid Resistance (mm Hg) 160 160 (PASS)
    Bacterial Filtration Efficiency (BFE) @3.0 µm ≥ 98% ≥ 99.9% (PASS)
    Particulate Filtration Efficiency (PFE) @0.1 µm ≥ 98% ≥ 99.6% (PASS)
    Breathability (Change in Pressure) in mm H2O/cm2 < 5.0 5.6 (PASS)
    Flame Spread Class I Class I (PASS)
    Purposes. Indoor & Outdoor Use.
    Filters dust & fluid droplets.
    Filters airborne particles & aerosol - pollen, dust, & microorganisms.
    Sizing. FLORA sells surgical & procedural masks that are adjustable to fit almost any face.
    Children or those with specialized needs should consult a professional.
    Proper Use. Consult a professional to learn proper use and techniques.
    - Wash your hands thoroughly before handling your face mask.
    - Inspect the mask for defects or damage.
    - Plast your face mask onto the face, starting from below the chin.
    - Pull the mask upwards towards the nose and attach the ear straps around your ears.
    - Lightly pinch the optional nose bar around your nose, and check for a tight fit.
    - The mask should feel snug on your face and there should be no gaps between the mask and your skin.
    - With your hands away from your face and mask, breath in and out several times. If gaps appear while breathing, adjust until the seal remains constant.
    - Wash your hands after removing the face mask.
    Avoid touching the inside of the mask with your hands and never let your face or mouth touch the outside of the mask. Wash your hands early & often when handling.
    Materials. Multi-layer non-woven polypropylene.
    Warnings & Precautions. - Failure to ensure proper facial fit will result in inadequate filtration & protection.
    - Always double check that the mask has formed a snug fit with no gaps when first applying the mask.
    - Your hands can contaminate a clean mask. Wash your hand prior to applying a mask.
    - Masks filter things like pollen, dust, & microorganisms. These can remain on the outside of a mask. Wash your hands after handling or removing a mask.
    - Replace masks if they become damaged or if you feel an increased resistance in breathing.
    - Use duration is recommended at 4 hours.
    - Surgical & procedural masks are not washable. If you wash this item, it may become damaged, and its filtration capabilities will be diminished. Washing these masks will cause penetration and damage to the absorption force of filter material.
    - Story in a clean, dry environment (28° to 86° F, Less than 80% Humidity).
    - Keep masks out of direct sunlight.
    - Avoid storage in high temperatures.
    - Avoid chemical pollution.
    Disclaimer. These surgical & procedural masks are not meant to protect users from any specific disease. These surgical & procedural masks are for sanitary and disposable use, thus all sales are final and no returns or refunds are available. These masks are Made in China. They are CE certified & FDA-cleared.
  • Certifications
    Certification Cert. / Product Code
    FDA Cleared. Product Code: FXX FDA Registration & FDA.GOV Listing.
    CE Certified Factory for Surgical & Procedural Masks

Flora Med Supplies Products

We have a FDA approved medical supplies from CE certified production facilities for hospitals and other essential service providers, as well as excess stock of protective equipment available for public purchase.


There are a great many questions about our medical supplies and PPE. Please don't hesitate to email us for more details →

  • Why aren't all FLORA products available for purchase for personal use?

    FLORA provides PPE to hospitals and healthcare workers who are in desparate need of these supplies. Under no circumstances can the general public purchase items which are in short-supply and high-demand with those on the front lines. These supplies are in desparate need by healthcare workers who are in high-risk scenarios. If you attempt to purchase these from another supplier, you are not only putting healthcare staff at higher risk, but you endanger the public and your loved ones.

  • Can I donate PPE to healthcare workers in need?

    FLORA donates in-demand personal protective equipement (PPE) to hospitals in its area. You can help that cause by donating to a non-profit like:
    Direct Relief 501(c)3

  • How do I place large orders with FLORA?

    FLORA has dealt with orders for governments and hospitals. We are ready to handle all of your large ordering needs. This service is currently only available for governments, hospitals, other healthcare services, and select essential services.
    Contact us here →