LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130101
    Device Name
    BYTECH
    Manufacturer
    BYTECH DONGTAI CO., LTD.
    Date Cleared
    2013-11-08

    (297 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K091663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).

    AI/ML Overview

    Here is an analysis of the acceptance criteria and study information for the device, based on the provided text:

    Acceptance Criteria and Device Performance Study

    The device in question is the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". Its performance is demonstrated through testing against established ASTM standards and FDA regulations for examination gloves.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06 (Reapproved 2011)Meets
    Physical PropertiesASTM standard D 5250-06 (Reapproved 2011)Meets
    Freedom from Pinholes21 CFR 800.20Meets (specifically, Meets ASTM D5151-06 (Reapproved 2011) Holes at Inspection Level I AQL2.5)
    Powder ResidualASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011)Meets (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1