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510(k) Data Aggregation

    K Number
    K022220
    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2002-09-23

    (76 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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. This device is not intended to be used as a chemical barrier.

    Device Description

    Textured Powder-Free Latex Examination Gloves with Protein Claim ( Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram), Green Color

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Textured Powder-Free Latex Examination Gloves with Protein Claim". It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.

    The letter does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It mentions protein claims (containing 50 micrograms or less of total water extractable protein per gram) but it doesn't describe the testing or study conducted to verify this claim.

    Therefore, I cannot provide the requested information based on the provided text.

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