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Surgical Mask

The COVID-19 pandemic has led to an insufficient supply and availability of surgical masks worldwide.  In response to this shortage, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) so as to simplify the clearance procedure for masks to be supplied in the U.S. 

Surgical masks that are in the scope and able to provide certain information and documentation are eligible to apply for EUA.  Surgical masks that are excluded from the scope are:

  1. FDA-cleared
  2. Manufactured in China
  3. Surgical masks that include drugs, biologics, nanoparticles, or antimicrobial / antiviral agents

Surgical masks to be eligible to apply for EUA shall meet with criteria stated in Table 1.

Table 1. Critical EUA Performance Requirements

Fluid Resistance Liquid barrier performance requirements consistent with ASTM F1862
Flammability Resistance Class 1 or Class 2 textile requirements consistent with 16 CFR Part 1610
Particulate Filtration Efficiency (PFE) Efficiency Requirements consistent with ASTM F2100
Air Flow Resistance (Breathability)

Air flow resistance requirement of <6 mm H2O/cm2 for differential pressure (delta P) testing consistent with ASTM F2100 (EN 14683 Annex C)

NOTE: Applicable only for masks composed of 4 or more layers

Biocompatibility Requirements

Materials used shall be either:

  • Non-cytotoxic, non-irritating and non-sensitizing consistent with the recommendations in FDA’s guidance, Use of International Standard ISO 10993-1, OR
  • Conform to the following biocompatibility standards:
    • ISO 10993-1
    • ISO 10993-5
    • ISO 10993-10

In addition to above performance requirements, applicants of EUA are also required submit certain information and fulfill the below labeling requirements:
  • Description of the product as a disposable, single-use surgical masks, and include a list of body contacting materials
  • State that the product is not intended to replace the need for FDA-cleared surgical masks
  • State that surgical masks are not intended to provide protection against pathogenic biological airborne particulates
  • Does not include any statements that could lead to misinterpretations

Providing a one stop shop, SGS’s global network of PPE experts and accredited laboratories can ensure the compliance of face masks and PPE products with certification and various testing services, including performance and EUA registration services. 

 

For enquiries, please contact us

 
To obtain a copy in PDF, please click here.