Responding to the call for American PPE, Premier Guard USA has contracted with US manufacturers to provide materials and produce face masks right here on American soil. Committed to bringing jobs back to the U.S. AND producing over one billion masks made by Americans for Americans, Premier Guard is leading the movement it founded, ByAmericans4Americans.com
Crafted with extremely high quality raw materials and American ingenuity, Premier Guard USA Level 3 and General Public face masks are available right here and now. Join the movement. Buy from Americans 4 Americans. This is our country. These are our doctors and nurses. We have their backs! Never again will we be vulnerable in a health care crisis by a lack of PPE!
Surgical Face Mask ASTM Level 3
Tested and in compliance with FDA ASTM Level 3 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 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
- Disposable surgical mask
- Elastic ear loops do not contain natural rubber latex
- 3-PLY Polypropylene Materials
- Dimensions 17.5 cm x 9.5 cm
- Blue, Non-Sterile and Single-Use
|Layer||Material||Body Contact (intact skin)|
|Inner Layer||Non-woven Polypropylene||Direct|
|Middle Layer||Melt Blown Polypropylene||Indirect|
|Outer layer||Non-woven Polypropylene||Indirect|
|Nose Strip||Polyethylene laminated double sided 24-gauge soft annealed carbon steel wire tie||Indirect|
|Elastic ear loops||Polyester/Spandex||Direct|
- The product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.
- In addition, the PGUSA 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 PGUSA 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 fluids 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.
General Public Face Mask
Premier Guard USA’s General Public Face Mask is made available under the FDA Emergency Use Authorization for face masks for use by the general public and healthcare personnel as source control per the FDA website. Source control means preventing the transmission of infection through a person’s respiratory secretions which are produced when speaking, coughing or sneezing. Face masks, including cloth face coverings, help with source control by covering the wearer’s mouth and nose. COVID-19 may be spread through respiratory secretions by individuals who may or may not have symptoms of COVID-19.
- 3-ply face mask non-woven (polypropylene)
- Elastic ear loops free of natural rubber latex
- Non-sterile and single-use, flexible nose strip
- Not for use in any surgical setting or where significant exposure to liquid, bodily, or other hazardous fluids may be expected
- Not for use in a clinical setting where infection risk level through inhalation exposure is high
Of all the lessons learned in the COVID-19 crisis, none is more apparent than America’s dependence on foreign companies providing critical PPE needs. And the only way to end this dangerous reliance is to start buying PPE from American comapnies, NOW! With Premier Guard’s ByAmericans4Americans.com initiative, we ask you to join us in supporting the American companies that support the American people!