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510(k) Data Aggregation

    K Number
    K023537
    Device Name
    NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2003-11-20

    (395 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.

    AI/ML Overview

    The document provided is a 510(k) Premarket Notification from the FDA for a medical device: "Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (

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