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510(k) Data Aggregation
K Number
K230093Device Name
Disposable 4 Layers Surgical Face Mask
Manufacturer
Date Cleared
2023-03-02
(49 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Social Medical Supply LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.
Device Description
The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.
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