LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252521
    Device Name
    LifeStyles® HydraFeel Natural Rubber Latex Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2025-11-18

    (99 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K163107
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

    Device Description

    The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

    The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1