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510(k) Data Aggregation
K Number
K955556Device Name
FLUID RESISTANT MASK
Manufacturer
Date Cleared
1996-04-25
(142 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN THRESHOLD HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
Device Description
The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose.
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K Number
K955557Device Name
FLUID REISISTANT EYESHIELD MASK
Manufacturer
Date Cleared
1996-04-25
(142 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN THRESHOLD HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
Device Description
The Fluid Resistant Eyeshield Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose. An optical quality eyeshield is attached to the mask by ultrasonic welding.
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