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Medtecs, safeguarding every tomorrow

Medtecs Group is the world's biggest provider of personal protective equipment (PPE) and a trusted multi-national PPE stockpiling solutions provider to governments and GPOs around the world.

  • Trusted national strategic stockpiling partner for 17 years
  • Diversified regional production facilities
  • Complete range of personal protective equipment
  • Worldwide distribution centers with stocks ready to ship
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Surgical Face Mask ASTM Level 1

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

For details consult the FDA website at https://www.fda.gov/medical-devices/coronavirus disease-2019-covid-19-emergency-use-authorizations medical-devices/personal-protective-equipment euas#surgicalmasks or:

The electronic instruction for use of our surgical mask at http://www.medtecs.com/en/attachments/category/139/DownloadIFU.pdf

 

The FDA Fact Sheet at https://www.fda.gov/media/140895/download or:

Appendix A for Authorized Face Masks 

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixasurgicalmasks


Features:

- Disposable surgical mask

- Elastic ear loops do not contain natural rubber latex

- 3-PLY Polypropylene Materials

- Dimensions 17.5 cm x 9.3 cm

- Green or Blue, Non-Sterile and Single-Use

Composition:



 

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FDA Information

The product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.

In addition, the MEDTECS Surgical Face Mask is not intended to provide protection against pathogenic biological airborne particulates and is not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure; and the MEDTECS product has not been FDA cleared or approved.

Rather, it has been authorized by the FDA under an 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 surgical mask shortages resulting from the COVID-19 pandemic.

This product is authorized only for the duration of the declaration that circumstances exist justifying 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.



Medtecs USA

2082 Business Center Drive, Irvine, CA 92612

Email: sales@medtecs.com

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