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510(k) Data Aggregation

    K Number
    K202085
    Device Name
    Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-06-21

    (329 days)

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

    Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

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

    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

    AI/ML Overview

    I am sorry, but this document contains no information regarding acceptance criteria or a study proving device performance for the "Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green" (K202085).

    The document is an FDA 510(k) clearance letter, which indicates that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device, its regulation, and general controls, but does not include details on performance studies or acceptance criteria beyond indicating its intended use as a medical examination glove.

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