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510(k) Data Aggregation

    K Number
    K250034
    Device Name
    Natural rubber latex male condom
    Manufacturer
    Shaoguan Regenex Pharmaceuticals Co., Ltd.
    Date Cleared
    2025-07-11

    (185 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Description

    Natural rubber latex male condom

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

    The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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