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510(k) Data Aggregation

    K Number
    K032293
    Manufacturer
    Date Cleared
    2003-08-28

    (34 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.

    AI/ML Overview

    The provided document does not describe an AI medical device. It pertains to a **Non-Sterile Powder-Free Green Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a Protein Labeling Claim (

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