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510(k) Data Aggregation

    K Number
    K140989
    Date Cleared
    2014-12-22

    (249 days)

    Product Code
    Regulation Number
    878.4460
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.

    Device Description

    Surgical glove is a disposable device worn on the surgical room personnel's hand or finger to prevent contamination during surgical procedures. The principle of operation is to provide a physical barrier between the surgical personnel's hands and the patient's open wound.

    The powder free nitrile surgical gloves described in this submission are made of synthetic nitrile rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have white color and are single use.

    The powder free nitrile surgical gloves described in this submission are tested for dimension, percent elongation, tensile, tensile at 500% elongation, free of pinholes, residue powder, water soluble proteins. The test results conform to related requirements in ASTM 3577-2009.

    The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard.

    The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.

    AI/ML Overview

    This document is a 510(k) premarket notification for Powder Free Sterile Nitrile Surgical Gloves, White Color (Brand Name: Titanfine). It does not describe a study involving an AI device and human readers, but rather the substantial equivalence of a medical device (surgical gloves) to a predicate device. Therefore, many of the requested categories related to AI performance, human expert evaluation, and training/test sets are not applicable.

    However, I can extract the acceptance criteria and demonstrated performance for the surgical gloves based on the provided text.

    Here's a summary of the requested information, adapted for this medical device submission:

    1. A table of acceptance criteria and the reported device performance

    DescriptionAcceptance Criteria (Predicate Device K122557)Reported Device Performance (Subject Device K140989)
    Dimension
    Length≥265 mm≥265 mm
    Widthwithin ±6 mm of specified value in ASTM 3577:2009within ±6 mm of the specified value in ASTM 3577:2009
    Palm, Finger, Cuff Thickness≥0.10 mm≥0.10 mm
    Tensile Strength (MPa)≥17≥17
    Tensile at 500% Elongation (MPa)≤ 7.0≤ 7.0
    Percent Elongation≥650≥650
    Free of PinholeFree of pinholes at AQL = 1.5Free of pinholes at AQL = 1.5
    Residue Powder≤ 2.0 mg≤ 2.0 mg
    Water Soluble Protein≤ 200 µg/dm²≤ 200 µg/dm²
    Primary Skin Irritation (ISO 10993-10: 2010)Not a primary skin irritantNot a primary skin irritant (Grade
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