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510(k) Data Aggregation

    K Number
    K070139
    Device Name
    WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
    Manufacturer
    SURVIVAIR, INC.
    Date Cleared
    2007-03-02

    (45 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURVIVAIR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSHapproved N95 single use respirator intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter. The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.
    Device Description
    The Willson ONE-Fit HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a one size fits all, cup type, particulate respirator and surgical mask. The inner layer is constructed of polypropylene; the middle layer is a filtration layer made of polypropylene; and the outer layer is a covering of non woven polyester. The cup is thermoformed while the perimeter layers are heat sealed to form a small flange around the perimeter of the mask. Two latex free, synthetic elastic straps are stapled to the flange and are used to secure the mask to the wearer's face. The Willson ONE-Fit HC-NB095 is approved by NIOSH in accordance with 42 CFR Part 84. NIOSH has issued certification number TC-84A-4357 as a type N95 Particulate Respirator. It is a single use, disposable device.
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    K Number
    K962443
    Device Name
    N95 FILTERING FACEPIECE
    Manufacturer
    SURVIVAIR, INC.
    Date Cleared
    1997-01-03

    (193 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURVIVAIR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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