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510(k) Data Aggregation

    K Number
    K020586
    Device Name
    GOOD LUBRICATIONS
    Manufacturer
    BIOFILM, INC.
    Date Cleared
    2003-01-24

    (336 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GOOD LUBRICATIONS

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

    Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

    Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.

    Good lubrications may be used with condoms.

    Device Description

    Good Lubrications Personal Lubricant

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA for a device named "Good Lubrications." This document does not describe acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

    Instead, it is a letter from the FDA to BioFilm, Inc. stating that their device has been found substantially equivalent to legally marketed predicate devices. This means the device can be marketed in the US.

    Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies from this document. The document is an administrative approval of a medical device based on substantial equivalence, not a medical device performance study report.

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