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510(k) Data Aggregation

    K Number
    K993271
    Device Name
    QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
    Manufacturer
    QUALITY LATEX CORP. SDN BHD
    Date Cleared
    1999-12-02

    (63 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 is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Quality Latex Powdered Examination Gloves with Protein Labeling Claim of 170 micrograms or less." It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is specifically about the regulatory approval of a medical glove.

    Therefore, I cannot provide the requested information.

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