LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141581
    Device Name
    ASTROGLIDE NATURAL
    Manufacturer
    BIOFILM, INC.
    Date Cleared
    2014-08-06

    (54 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K072647
    Why did this record match?
    Device Name :

    ASTROGLIDE NATURAL

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

    Astroglide® Natural is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is ONLY compatible with natural rubber latex and polyisoprene condoms.

    Device Description

    Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device (personal lubricant) and does not contain information about the acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device.

    The document describes the "Astroglide Natural" personal lubricant and its substantial equivalence to a predicate device, "Glycerin and Paraben Free Astroglide." It outlines:

    • Indications for Use: Moisturize and lubricate to enhance intimate sexual activity and compatible with natural rubber latex and polyisoprene condoms.
    • Technological Characteristics: Comparison of ingredients, storage, pH, osmolarity, viscosity, and condom compatibility between the proposed device and the predicate.
    • Biocompatibility Testing: Results of cytotoxicity, guinea pig maximization, vaginal irritation, penile irritation, and systemic toxicity tests.
    • Specifications: Lot release specifications for quality control (color, clarity, odor, pH, viscosity, microbial counts).
    • Shelf Life: 3 years based on real-time and accelerated aging studies.
    • Condom Compatibility Testing: Tested with ASTM D7661-10, showing compatibility with latex and polyisoprene, but not polyurethane.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device, as this document is for a personal lubricant and does not involve AI or ML.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1