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510(k) Data Aggregation

    K Number
    K013846
    Device Name
    ULTRAGARD IMPERVIOUS REINFORCED GOWN
    Manufacturer
    PRECEPT MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-05-22

    (183 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K842115
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.

    Device Description

    The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.

    AI/ML Overview

    The provided text describes a 510(k) submission for a surgical gown and therefore does not include information relevant to a medical device that utilizes AI/ML or requires a study with a test set, ground truth establish by experts, or training set as described in the prompt. The "device" in this context is a physical product (a surgical gown), not a software algorithm.

    Therefore, most of the requested fields are not applicable.

    Here's an analysis of the provided text based on the categories you've requested, highlighting why many are not present:

    Acceptance Criteria and Device Performance for UltraGard™ Blue Operating Room Gown

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Standard)Reported Device Performance
    ASTM F1670-98 (Resistance to Penetration by Synthetic Blood)Pass (in the reinforced gown areas)
    ASTM F1671-97b (Viral Penetration)Pass (in the reinforced gown areas)
    National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability"Meets Class 1
    ISO 10993 (Biocompatibility for surface devices, intact skin, limited duration (
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