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510(k) Data Aggregation
K Number
K141085Device Name
WestTec Procedure Facemask;WestTec Surgical Facemask
Manufacturer
Date Cleared
2015-03-27
(333 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
WESTTEC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
Device Description
The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.
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