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510(k) Data Aggregation

    K Number
    K970547
    Device Name
    ISOLYSER SDS SHARPS CONTAINER
    Date Cleared
    1997-07-18

    (156 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    THANTEX SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Isolyser SDS is a sharps container intended for use in non-clinical settings for the disposal of contaminated sharps.
    Device Description
    The Isolyser Syringe Disposal System (SDS) has the same uses as other sharps containers in commercial distribution: to provide safe and effective disposal of medical sharps. The major difference between the Isolyser SMS 1000 and the SDS relate to the setting in which the device will be used. The SDS is intended for use in non-clinical settings while the Isolyser SMS 1000 is used in clinical settings. As is true for the Isolyser SMS 1000, the SDS is closable, puncture resistant and leakproof on the sides and the bottom. The fluorescent orange BIOHAZARD warning labels are clearly visible with lettering in contrasting color and are affixed by adhesive to the SDS containers. Like the SMS 1000, the SDS container maintains a stable and upright position. There is no feature to bend, break, or shear the needle off the hub of the syringe. When the SDS is full, the user adds water to the SDS to activate the "Gel-loc" system. After replacing the cap on the SDS, the user shakes the container well. The user then places the SDS into the carton provided and seals it with tape. The user then disposes of the sealed carton according to local, state and federal laws. The disposal methods for the SMS 1000 and the SDS are quite similar. As is true for SMS 1000, the SDS containers are designed so that no user is required to reach by hand into the container to retrieve the contaminated reusable sharps. As indicated on all labels for SDS containers, safe and effective disposal of the waste is easily accomplished.
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    K Number
    K961083
    Device Name
    OREX SURGEON'S VEST
    Date Cleared
    1996-08-23

    (157 days)

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

    THANTEX SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. The material is flame resistant, and is resistant to fluid penetration. The material also has low lint characteristics, meets suitable strength requirements for its intended use, and is resistant to tearing. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method.
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