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510(k) Data Aggregation

    K Number
    K014230
    Device Name
    STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
    Manufacturer
    SUPERMAX GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2002-03-13

    (77 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

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

    A surgeon's-glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

    Device Description

    Sterile Powder Free Latex Surgeon Gloves with Protein Content Labeling Claim (50 micrograms or less)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Latex Surgeon's Gloves with Protein Labeling Claim (50 Micrograms or Less Per Gram of Glove)". It does not contain information about acceptance criteria and device performance in the context of a study for an AI/ML powered device.

    The information provided describes the regulatory classification of the gloves, the predicate device, and general regulatory requirements for marketing the device. It also includes the indicated use of the gloves.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics from this document.

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