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510(k) Data Aggregation

    K Number
    K173766
    Device Name
    PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2018-07-08

    (209 days)

    Product Code
    LZC,LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.

    Device Description

    Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs

    AI/ML Overview

    This document describes the acceptance criteria and the study results for the "Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs".

    Here's the breakdown of the requested information:

    1. A table of acceptance criteria and the reported device performance

    The acceptance criteria for gloves used with chemotherapy drugs are typically based on the "breakthrough detection time" of various chemotherapy drugs as per ASTM D6978-05. While the document doesn't explicitly state a minimum acceptance time for all drugs (other than the general implication that a longer breakthrough time is better), the reported performance indicates that breakthrough times greater than 240 minutes are considered acceptable for most. However, two drugs showed significantly shorter breakthrough times, which the manufacturer highlights with a warning.

    Chemotherapy Drug and ConcentrationBreakthrough Detection Time in Minutes (Acceptance Criteria Implicitly >240 min for safe use)Reported Device Performance (Breakthrough Detection Time in Minutes)
    1. Carmustine (BCNU), 3.3mg/mlNot explicitly defined, but 240>240
    3. Cyclophosphamide (Cytoxan), 20mg/ml>240>240
    4. Dacarbazine (DTIC) 10mg/ml>240>240
    5. Doxorubicin Hydrochloride, 2.0 mg/ml>240>240
    6. Etoposide (Toposar), 20mg/ml>240>240
    7. Fluorouracil 50mg/ml>240>240
    8. Paclitaxel (Taxol), 6.0mg/ml>240>240
    9. Thiotepa, 10mg/mlNot explicitly defined, but
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