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510(k) Data Aggregation

    K Number
    K202081

    Validate with FDA (Live)

    Device Name
    Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-03-19

    (235 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document contains a letter regarding medical device clearance (K202081) for "Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue." It discusses regulatory aspects, such as compliance with FDA regulations (21 CFR 880.6250), labeling, and reporting requirements.

    However, this document does not contain any information about an AI/ML device, its acceptance criteria, or the study proving its performance. Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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