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510(k) Data Aggregation

    K Number
    K000572
    Device Name
    E.N.S.I. SYRINGE
    Manufacturer
    TRI-JECT INTL. CORP.
    Date Cleared
    2000-02-24

    (2 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRI-JECT INTL. CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K984512
    Device Name
    NITRILON CORRECT-TOUCH
    Manufacturer
    CT INTL.
    Date Cleared
    1999-07-12

    (206 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    CT INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This sterile nitrile powder free surgeon's glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Nitrilon™ Correct Touch® Sterile Nitrile Powder Free Surgeon's Glove
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    K Number
    K981304
    Device Name
    NITRILON CORRECT-TOUCH
    Manufacturer
    CT INTL.
    Date Cleared
    1998-06-22

    (73 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CT INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical giove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    NITRILON CORRECT-TOUCH POWDERED NITRILE Examination Glove
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