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510(k) Data Aggregation

    K Number
    K222534
    Device Name
    Nitrile Patient Examination Glove
    Manufacturer
    Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
    Date Cleared
    2022-11-23

    (93 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211914
    Why did this record match?
    Reference Devices :

    K211914

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

    The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.

    This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.

    Here's a breakdown of the relevant information provided:

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.

    Test / CharacteristicAcceptance Criteria (Standard Reference)Reported Device Performance
    Biocompatibility
    Irritation (ISO 10993-10:2010)Primary Irritation Index: 0-0.4 (Negligible)Primary irritation index is 0. Response categorized as negligible. All animals survived with no abnormal signs.
    Sensitization (ISO 10993-10:2010)Grades less than 1 (no sensitization)All grades are 0. Not a sensitizer under study conditions.
    Cytotoxicity (ISO 10993-5:2009)Viability (viab.%) of 100% extract ≥ 70% of blank (no cytotoxic potential)Viab.% of 100% test article extract is 70.9%. No potential toxicity to L-929 in MTT method.
    Physical Properties
    Residual Powder (ASTM D6124-06)
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