LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K111297
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
    Manufacturer
    PREMIER MEDICAL GLOVES FACTORY
    Date Cleared
    2011-06-16

    (38 days)

    Product Code
    LYZ
    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

    Synthetic Vinyl Examination Glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Synthetic Vinyl Examination Gloves, Powder-Free

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.

    This document does not contain any information about:

    • Acceptance criteria for device performance
    • A study proving the device meets acceptance criteria
    • Sample sizes for test or training sets
    • Data provenance
    • Ground truth establishment or type
    • Number or qualifications of experts
    • Adjudication methods
    • Multi-reader multi-case (MRMC) comparative effectiveness studies
    • Standalone algorithm performance studies

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1