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510(k) Data Aggregation

    K Number
    K003867
    Device Name
    EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
    Manufacturer
    BIOFILM, INC.
    Date Cleared
    2001-03-09

    (87 days)

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

    EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)

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

    A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments.

    Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to BioFilm, Inc. regarding their Exam Room Astroglide and Target Lubricating Jelly devices.

    This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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