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510(k) Data Aggregation

    K Number
    K031408
    Device Name
    DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
    Manufacturer
    DEROYAL
    Date Cleared
    2003-10-15

    (163 days)

    Product Code
    FYA
    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

    DeRoyal Poly-Reinforced Surgical Gowns are surgical attire that is worn by operating room personnel to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials during surgical procedures.

    Device Description

    DeRoyal Poly-Reinforced Surgical Gowns

    AI/ML Overview

    The provided FDA 510(k) clearance letter (K031408) for the "Deroyal Poly-Reinforced Surgical Gowns" does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically found for AI/ML-driven devices or diagnostic tools.

    This document is a clearance letter for a Class II medical device (Surgical Apparel) under regulation 878.4040. The clearance is based on substantial equivalence to a legally marketed predicate device, not on specific performance criteria demonstrated through a clinical study or AI algorithm validation study.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to existing devices rather than a detailed performance study with acceptance criteria.

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