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510(k) Data Aggregation

    K Number
    K203191
    Device Name
    LYDUS Nitrile Examination Gloves, Powder Free
    Manufacturer
    Nathan Trading Co., Ltd
    Date Cleared
    2021-02-12

    (108 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K192333
    Predicate For
    K211075,K211708,K212551,K212600,K212840,K213859
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

    Device Description

    The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for LYDUS Nitrile Examination Gloves, Powder Free. It aims to demonstrate that this device is substantially equivalent to a predicate device already legally marketed. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to show the new device performs as safely and effectively as the predicate device, adhering to relevant standards.

    Here's the information extracted from the provided text, formatted to address your questions. Please note that this document does not pertain to AI/ML medical devices, so many of your questions related to multi-reader multi-case studies, expert adjudication, or training/test sets for algorithms are not applicable and will be marked as such.

    Device Performance Study Details

    The study focuses on demonstrating the substantial equivalence of the LYDUS Nitrile Examination Gloves, Powder Free to a legally marketed predicate device (K192333, "Blue Nitrile Examination Gloves Powder Free"). This is achieved through non-clinical performance testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Device: LYDUS Nitrile Examination Gloves, Powder Free

    Test MethodPurposeAcceptance CriteriaReported Device Performance (Result)
    Physical Dimensions (ASMT D6319-19)To determine the width, length, and thickness of the gloves.Width: 91 mm (Mean) (for medium size)
    Length: 241 mm (Mean) (for medium size)
    Thickness: Finger - 0.13 mm (Mean), Palm - 0.09 mm (Mean)Passed (Specific measurements not detailed in "Result" column, but stated as "Passed")
    Physical Requirements (ASMT D6319-19)To determine the tensile strength and ultimate elongation before and after acceleration aging.Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean)
    After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571 (Mean)Passed (Specific measurements not detailed in "Result" column, but stated as "Passed")
    Freedom from Holes (ASTM D6319-19 / ASTM D5151-11)To determine the holes in the gloves (water tight - 1000 ml).AQL 2.5Passed
    Residual Powder (ASMT D6319-19 / ASTM D6124-11)To determine the residual powder in the gloves.
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