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510(k) Data Aggregation

    K Number
    K994013
    Device Name
    POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
    Manufacturer
    GLOVCO (M) SDN. BHD.
    Date Cleared
    2000-01-20

    (55 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 patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.

    Device Description

    Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS)

    AI/ML Overview

    The provided text is a 510(k) pre-market notification letter from the FDA regarding "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less)". This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, or performance results of a device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly for regulatory approval of a medical device based on substantial equivalence.

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