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510(k) Data Aggregation

    K Number
    K220209
    Device Name
    Powder Free Nitrile Examination Glove, Non-sterile (Blue)
    Manufacturer
    KSG MEDICARE Sdn. Bhd.
    Date Cleared
    2022-04-11

    (75 days)

    Product Code
    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 Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the hand or finger to prevent contamination between examiner and patient.

    Device Description

    Powder Free Nitrile Examination Glove, Non-sterile (Blue)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, or performance study data.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The information requested (e.g., sample sizes, expert qualifications, ground truth, MRMC studies) is relevant to the evaluation of AI/ML devices, not to a simple medical device like examination gloves.

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