Homeland AMPP Mask Bundle`
The Homeland AMPP (American Made Personal Protective) Mask is a patent-pending, American Made injection molded product developed in response to the recent COVID-19 pandemic. It is designed as a reusable mask that comes with a 10-pack of replacement filters. Nine Line is applying for Expedited FDA approval on this mask. Still, until they receive authorization from the FDA, we cannot publish independent testing nor can we make any claims about its effectiveness against COVID-19 or any other pathogen. As such we must promote the use of FDA approved medical devices over ours and unequivocally state that:
(1) This product has not been FDA cleared or approved
(2) This product has been authorized by FDA under a EUA for use as source Control by the general public as well as by HCP in healthcare settings to help prevent the spread of infection or illness during the COVID-19 pandemic.
(3) 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.
(4) This product is not cleared by FDA for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high, or use in high-risk aerosol-generating procedures, and the product does not provide antimicrobial or antiviral protection or infection prevention or reduction.
- Face mask: Thermo Plastic Elastomer
- Filter Cage: Polypropylene
- Head strap: Thermo Plastic Elastomer
- Description: Injection Molded Mask Version 1
- Back Layer: PP nonwoven
- Front Layer: PTFE Membrane
- Width: 2.87 in.
- Height: 3.27 in.
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