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510(k) Data Aggregation

    K Number
    K012815
    Device Name
    SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
    Manufacturer
    KIMBERLY-CLARK CORP.
    Date Cleared
    2001-11-13

    (83 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K050152
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

    Device Description

    The powder-free latex exam glove with vitamin E and aloe meets the current specifications for ASTM D 3578-00a. The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device, specifically the "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove with Vitamin E and Aloe. It outlines the device's characteristics and its equivalence to a predicate device, as well as the FDA's approval.

    Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    CharacteristicsAcceptance Criteria (Standards)Reported Device PerformanceComments
    DimensionsMeets ASTM D 3578-00aMeets ASTM D 3578-00aConfirmed
    Physical PropertiesMeets ASTM D 3578-00aMeets ASTM D 3578-00aConfirmed
    Freedom from pinholesMeets ASTM D 3578-00aMeets ASTM D 3578-00aConfirmed
    Meets ASTM D 5151-99Meets ASTM D 5151-99Confirmed
    Powder FreeMeets ASTM D 6124-00aMeets ASTM D 6124-00aConfirmed
    Meets ASTM D 3578-00aMeets ASTM D 3578-00aConfirmed
    Protein ContentMeets ASTM D 5712-99 (
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