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510(k) Data Aggregation

    K Number
    K202845
    Device Name
    Bodygard SFS Surgical Gown Level 3
    Manufacturer
    Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi
    Date Cleared
    2022-02-24

    (517 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202844
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.

    Device Description

    The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL).

    Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.

    AI/ML Overview

    The provided document is limited to a 510(k) summary for a surgical gown (Bodygard SFS Surgical Gown Level 3). It details non-clinical performance and substantial equivalence to a predicate device, but it does not contain information on clinical studies, AI algorithms, or human reader performance. Therefore, I cannot answer questions related to those topics.

    Here's a breakdown of what can be extracted from the document regarding acceptance criteria and non-clinical studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test Method (Purpose)Acceptance CriteriaReported Device Performance
    AATCC 127 (Water resistance Hydrostatic Pressure)>50cmH2O (AQL 4%, RQL=20%)All were > 50cmH2O
    AATCC 42 (Water Resistance impact penetration)30 N (AQL 4%, RQL=20%)All were >30N
    ASTM D5587-14 (Tearing Strength)>20 N (AQL 4%, RQL=20%)All were >20 N
    16 CFR 1610 (Flammability testing)Class IMeets Class I
    ASTM D4169-16 (Seam Strength)>50 N (AQL 4%, RQL=20%)All were >50 N
    D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers)>500 gram/m2 Day WVTRPassed
    ASTM D3776/D (Mass Per Area (Weight) of fabric)-Has met acceptance criteria
    ASTM F1670 (Resistance by synthetic Blood)No Penetration at 2 psi (13.8 kPA)Passed
    ISO 9073-10:2003 (Lint and Other particles generation in the dry state)Log 10
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