LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990701
    Device Name
    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
    Manufacturer
    OMNIGRACE (THAILAND) LTD.
    Date Cleared
    1999-05-05

    (63 days)

    Product Code
    LZA
    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 medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Omni Flex Nitrile Examination Glove, Powder Free, Purple

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding "Omni Nitrile Flex Examination Glove, Powder-Free, Purple." It does not contain information about the acceptance criteria and study proving device performance as requested in the prompt.

    Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1