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510(k) Data Aggregation

    K Number
    K210148
    Device Name
    Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
    Manufacturer
    Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
    Date Cleared
    2022-04-13

    (447 days)

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

    Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120430, 8120450, 8120460) is intended to be worn by healthcare personnel to protect patients and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

    Flosteril Poly-Reinforced Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70)

    It is a single use, disposable medical device provided non-sterile and not intended for use in operating rooms. The medical device will be available in 15 models in Large, X Large and XX Large sizes.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for Flosteril Poly-reinforced Isolation Gowns. It states that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain information about acceptance criteria and device performance from a study for an AI/ML powered device. It describes a physical medical device (isolation gowns) and its intended use, classifications, and regulatory compliance.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided text.

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