How do you know if a mask is ASTM and FDA approved?

How do you know if a mask is ASTM and FDA approved?

EcoGaurd Inc & Mavina Inc both have more than 10 years+ in Non-woven Industry.
The owner of Ecoguard has 20 years+ PPE manufacturing experience;
The owner of Mavina has more than 15 years+ seasoned experience in USA and EU Medical Consumables marketplace.

Medical Face Mask Keys Points:
1. Before COVID-19 pandemic, there is no General Public Use face mask in US market.
2. Except for Cloth Mask and Costume Mask, Medical Face Mask is the only classification regulated by FDA, the product code is FXX under regulation number 878.4040.



3. Medical Face Mask must meet ASTM F2100-19 requirements, see below picture and  chart:


4. Conventionally, we classify as 2 types of medical face masks in different scenarios

Procedure Mask

  • Three or four layer construction
  • Utilizes two elastic straps (earloop), worn around the ears to secure the mask to the wearer’s face
  • Not suitable for use in the OR, suitable for Public Source Control during pandemic, such as COVID-19 and Monkeypox, etc.
  • Commonly used across the hospital and in patient isolation, sterile core, sterile processing, Labor & Delivery (L&D), Emergency Room (ER), and Intensive Care Units (ICU)

Surgical Masks

  • Three or four layer construction
  • Utilizes two straps – one tied at the crown of the head and the other behind the neck – to secure the mask to the wearer’s face
  • Intended for use when a surgical mask is required
  • Primarily used by OR staff

5. Why does the FDA issue Emergency Use Authorizations (EUAs)?
On August 5, 2020, the FDA issued an umbrella EUA for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorized the emergency use of surgical masks that met certain performance requirements for use in healthcare settings by health care personnel (HCP) as PPE, to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.

6. Now we have enough supply resources to mitigate surgical mask shortages by EUAs and 510Ks. Verification Website at FDA:
510K database:
Search Manufacturers/Brand Name in Applicant Name Area to Verify if medical face mask is already got 510K clearance.

Umbrella EUA database:
Search Manufacturers Name only.

7. If you cannot find your medical face masks at FDA website, then it is not FDA approved Medical Face Masks.

8. Addtional Info:

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