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510(k) Data Aggregation
K Number
K210101Device Name
American-Made Surgical Mask
Manufacturer
Date Cleared
2022-01-26
(377 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Armbrust Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. For adult use.
Device Description
The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier.
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