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510(k) Data Aggregation

    K Number
    K230384
    Device Name
    PolyWear® Personal Protective Level 3 Gown
    Manufacturer
    Polyconversions, INC
    Date Cleared
    2023-08-11

    (178 days)

    Product Code
    QPC,OPC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PolyWear**®** Personal Protective Level 3 Gown

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

    The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

    The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).

    Device Description

    The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "PolyWear® Personal Protective Level 3 Gown." This document outlines the regulatory approval for the gown and its intended use, but it does not contain information about acceptance criteria for an AI/ML device, nor does it describe a study proving the device meets such criteria.

    The document primarily focuses on:

    • Regulatory Classification: Identifying the device as a Class II surgical apparel.
    • Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
    • General Controls: Listing the general regulatory requirements the manufacturer must adhere to.
    • Indications for Use: Describing the intended purpose of the gown to protect against microorganisms, body fluids, and particulate material, specifically mentioning it meets AAMI Level 3 barrier protection.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, as this document pertains to a physical medical garment and not a software-based AI/ML device.

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