LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992117
    Device Name
    PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
    Manufacturer
    PAMITEX INDUSTRIES SDN BHD
    Date Cleared
    1999-09-27

    (96 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

    Device Description

    Pre-powdered Latex Examination Gloves Powdered with Oat Starch Powder

    AI/ML Overview

    This document is a 510(k) summary for a pre-powdered latex examination glove. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The document is a clearance letter from the FDA to Pamitex Industries Sdn. Bhd. for their "Pre-Powdered Latex Examination Glove with Trade Name: Oat-Starch Powder." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information from this document. The questions you posed are typically relevant to the performance evaluation of AI/ML software as a medical device, which is not what this document addresses.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1