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510(k) Data Aggregation

    K Number
    K111535
    Device Name
    EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
    Manufacturer
    EXACT MEDICAL MANUFACTURING, INC
    Date Cleared
    2011-08-26

    (85 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K964142
    Why did this record match?
    Device Name :

    EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER

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

    Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    The Exact Medical Manufacturing Surgical Gown - Sounlace w/PE Laver are also sold as built nonsterile, single use items, to repackagerrelabeler establishments for further packaging and ethylene oxide sterilization.

    Device Description

    Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns using in the OR as a protective covering, for the operating room staff, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester cuffs, Velcro neck closure, reinforced areas fabric or polyethylene

    AI/ML Overview

    This document describes the 510(k) submission for Exact Medical Manufacturing's Surgical Gowns – Spunlace w/PE Layer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-based device. Therefore, many of the requested categories related to AI device evaluation (e.g., AI integration, multi-reader multi-case studies, training set details) are not applicable.

    Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criteria (Implicit from "met acceptance criteria")Reported Device Performance
    Barrier PropertiesEquivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards."All results of the testing met acceptance criteria."
    Tensile StrengthEquivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards."All results of the testing met acceptance criteria."
    Tear StrengthEquivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards."All results of the testing met acceptance criteria."
    FlammabilityEquivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. (Typically per 16 CFR Part 1610 for apparel textiles.)"All results of the testing met acceptance criteria."
    LintingEquivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards."All results of the testing met acceptance criteria."
    SterilityAchieves sterility through Ethylene Oxide (ETO) process meeting AAMI 11135-1:2007 (Sterilization of Healthcare Products) with specific parameters:
    • Pre-Conditioning: Temperature = 42°C, RH = 60%, Dwell Time = 6 hours
    • EO Cycle: Temperature = 54°C, RH >= 30%, EO Concentration = 730mg/m3, Dwell Time = 9 hours
    • Aeration: Temperature = ambient, Time >= 72 hours
    • EO Residuals: EO
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