Black Surgical Face Mask ASTM Level 1

A medical face mask is intended to be worn by health professionals during healthcare procedures. Surgical masks are intended to prevent infections in patients and treating personnel by catching bacterias in liquid droplets and aerosols from the wearer’s mouth and nose.  There is a predominance of evidence that medical face masks protect both the wearer and persons near the wearer from the spreading of viruses.

About Face Masks

MedTecs - Safeguarding Every Tomorrow

3 Important points for mask selection

the 4Fs You need to consider

  1. Filtration: Ensure your face mask provides a sufficient filtration rate for your protection. If you work in an area with higher risk, make sure your face mask provides the right type of coverage.
  2. Fluid resistance: If you work in a medical area, your mask needs to provide a fluid-resistant function to prevent any chance of blood or other bodily fluid splatters. 
  3. Fit: Even the correct mask you exposed at risk if it is not worn correctly. Your nose and mouth area must be covered.  Any gaps can increase the risk of inhalation exposure.
Face Mask and Covid 19

3 Levels of ASTM Face Mask Protection

Mask level? Follow the ASTM Guide

ASTM International tests define more than 12,500 international standards across a wide variety of services and industries, including barrier protection standards for medical masks. 

  1. Level 1: low barrier protection for general use for low-risk, nonsurgical procedures, and exams that do not involve aerosols, sprays, and fluids. ASTM level 1 mask is the general standard for both surgical and procedural use.
  2. Level 2: moderate barrier protection for low-to-moderate levels of aerosols, sprays, and fluids.
  3. Level 3: maximum barrier protection for any situation that has the potential for exposure to heavy levels of aerosols, sprays, and fluids. Reference

“When choosing the right mask, always look to the level of protection that is recommended by ASTM,”

Medtecs Face Mask

Tested and in compliance with FDA ASTM Level 1 requirements; designed to provide splash resistance in various environments.

FDA Regulation

MEDTECS Surgical Face Mask has been authorized by the FDA under a EUA for use in healthcare settings by HCP as PPE to provide a physical barrier to liquids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during the COVID-19 pandemic. 

This product is authorized only for the circumstances that justify the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

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