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510(k) Data Aggregation

    K Number
    K960552
    Device Name
    KNIGHT LIGHT NONLUBRICATED CONDOM
    Manufacturer
    GLOBAL PROTECTION CORP.
    Date Cleared
    1997-11-20

    (651 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KNIGHT LIGHT NONLUBRICATED CONDOM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KNIGHT LIGHT™ CONTRACEPTIVES, if properly used, are intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, KNIGHT LIGHT™ CONTRACEPTIVES can reduce the risk of pregnancy.

    Device Description

    Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is a 510(k) clearance letter from the FDA for "Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)", indicating that the device has been found substantially equivalent to a predicate device.

    The information primarily discusses:

    • Device Name: Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)
    • 510(k) Number: K960552
    • Regulatory Class: II
    • Product Code: 85 HIS
    • Indications For Use: Reducing the risk of HIV infection (AIDS), other sexually transmitted diseases, and pregnancy (when properly used).
    • Classification: Over-The-Counter Use

    There are no details about specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in the 510(k) premarket notification submission itself, which is not provided here.

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