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510(k) Data Aggregation

    K Number
    K013317
    Device Name
    TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    TEKMEDIC (M) SDN BHD
    Date Cleared
    2001-12-17

    (74 days)

    Product Code
    LYY
    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 medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

    Device Description

    Tekmedic Powder-Free Latex Patient Examination Gloves with Aloe Vera Coating and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding "Tekmedic Powder-Free Aloe Care Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This type of document is a regulatory approval and does not describe a study that validates the performance of a device against acceptance criteria for algorithm-based medical devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval in this context.

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