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510(k) Data Aggregation

    K Number
    K212422
    Device Name
    Disposable Surgical Isolation Gown
    Manufacturer
    Crown Name Disposable Hygiene Products Fty.Ltd.
    Date Cleared
    2022-04-29

    (268 days)

    Product Code
    FYC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203415
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.

    Device Description

    The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
    The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.

    AI/ML Overview

    The provided text describes the acceptance criteria and study for a Disposable Surgical Isolation Gown, not an AI device. As such, information regarding AI-specific details like effect size improvement with AI assistance, standalone algorithm performance, or ground truth establishment for AI training sets is not present. Therefore, the response will focus on the details pertinent to the medical device described.

    Acceptance Criteria and Device Performance for Disposable Surgical Isolation Gown

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test ItemAcceptance CriteriaReported Device PerformanceResult
    Weight per square (g) (ASTM D3776)≥65g/m²Lot A: 66.88 g/m²
    Lot B: 67.86 g/m²
    Lot C: 66.92g/m²Pass
    Flammability (16 CFR Part 1610)Class 1: Burn time ≥ 3.5 secondsClass 1 (Results obtained from Three Lots)Pass
    Liquid Barrier Performance (AATCC-127) - Hydrostatic Pressure> 50 cm H₂O> 50 cm H₂O (3 non-consecutive lots tested, using a sample size of 32/lot)Pass
    Liquid Barrier Performance (AATCC-42) - Water Impact≤ 1.0 g≤ 1.0 g (3 non-consecutive lots tested, using a sample size of 32/lot)Pass
    Liquid Barrier Performance (ASTM F1671/F1671M-2013) - Blood-Borne Pathogen1. Assay titer (PFU/mL)
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