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510(k) Data Aggregation

    K Number
    K990669
    Date Cleared
    1999-05-17

    (76 days)

    Product Code
    Regulation Number
    884.5310
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)

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

    THESE DIFFERENT TYPES (NATURAL ORDINARY, NATURAL RIBBED, NATURAL DOTTED, AND NATURAL CONTOURED) OF NATURAL LATEX RUBBER CONDON (WITH NONOXYNOL-9) ARE USED FOR CONTRACEPTION AND FOR PROPHYLACTIC PURPOSES (TO PREVENT PREGNANCY AND THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD'S).

    Device Description

    Natural Ordinary, Natural Ribbed, Natural Dotted and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9)

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the Natural Ordinary, Natural Ribbed, Natural Dotted, and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9).

    The document is a 510(k) substantial equivalence letter from the FDA, addressing a correction to a previous letter and outlining regulatory requirements for the device. While it mentions the need for expiration dating supported by test data according to 21 CFR 801.435, it explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

    Therefore, I cannot provide the requested information from this document.

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