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510(k) Data Aggregation

    K Number
    K212109
    Device Name
    Spin Care Disposable Protective Mask Level 3
    Manufacturer
    Date Cleared
    2021-11-14

    (131 days)

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

    SpinTech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spin Care Disposable Protective Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These protective 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, provided non-sterile.
    Device Description
    The Spin Care Disposable Protective Mask Level 3 is a single use three-layer level 3 surgical mask. It houses a melt blown polypropylene filter between an outer and inner layer of spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. The mask is provided white, non-sterile and is flat-pleated. Contact duration is less than 24 hours. This device is not made with natural rubber latex.
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    K Number
    K201624
    Device Name
    Spin Care Disposable Protective Mask
    Manufacturer
    Date Cleared
    2021-03-18

    (276 days)

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

    SpinTech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spin Care Disposable Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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, provided non-sterile.
    Device Description
    The Spin Care Disposable Protective Mask is a single use multi-layer level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of Spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.
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