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510(k) Data Aggregation

    K Number
    K210405
    Device Name
    ProTEC-USA EZDoff Gown
    Manufacturer
    Cadillac Products, Inc.
    Date Cleared
    2021-12-15

    (308 days)

    Product Code
    QPC,OPC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K160337
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cadillac Products, Inc.

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

    ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff 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.

    Device Description

    The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.

    AI/ML Overview

    The document describes the acceptance criteria and study results for the ProTEC-USA EZDoff Gown, a non-sterile, single-use protective medical gown.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test Method (Reference Standard)Acceptance CriteriaReported Device Performance
    Flammability (CPSC, 16 CFR Part 1610)Average burn time ≥ 3.5sPass (Meets Class 1 Flammability)
    Hydrostatic Pressure (AAMI PB70:2012)AATCC 127 ≥ 50 cm, AQL of 4.0Pass (Meets Level 3 liquid barrier requirements)
    Water Impact (AAMI PB70:2012)AATCC 42 ≤ 1.0g, AQL of 4.0Pass (Meets Level 3 liquid barrier requirements)
    Breaking Strength (ASTM D5034)The standard does not include an acceptance criteria.52N (Machine Direction), 41N (Transverse Direction)
    Tearing Strength (ASTM D5587)The standard does not include an acceptance criteria.8N (Machine Direction), 22N (Transverse Direction)
    Linting (ISO 9073-10)The standard does not include an acceptance criteria.Log10
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