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510(k) Data Aggregation

    K Number
    K211360
    Device Name
    Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
    Manufacturer
    Pt. Universal Gloves
    Date Cleared
    2022-01-15

    (257 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Disposable Nitrile Powder Free Examination Gloves (Non-sterile)

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

    A powder-free nitrile examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.

    Device Description

    Disposable Nitrile Powder Free Examination Gloves (Non-sterile)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Disposable Nitrile Powder Free Examination Gloves (Non-sterile)." It is not a study describing acceptance criteria or performance data for an AI/ML medical device.

    Therefore, I cannot provide the requested information about acceptance criteria and study details as it pertains to AI/ML devices. The document concerns traditional medical devices (examination gloves) and focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than performance data against specific acceptance criteria for an AI algorithm.

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