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510(k) Data Aggregation

    K Number
    K211778
    Device Name
    Nitrile Examination Gloves, Green/ Blue/ Black Color
    Manufacturer
    Zhenjiang SuHui Latex Products Co., Ltd.
    Date Cleared
    2021-09-02

    (85 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K171422
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nitrile Examination Gloves,Green/ Blue/ Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.

    AI/ML Overview

    This document pertains to the 510(k) premarket notification for Nitrile Examination Gloves, Green/Blue/Black Color (K211778). The information provided describes the device, its intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.

    Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria and reported device performance are detailed in the "Summary of Non-clinical Testing" section (page 7 onwards) and specifically in the table.

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    ASTM D6319Physical Dimensions TestLength (mm): Blue/Green Color: XS/S: ≥220, M/L/XL: ≥230; Black: S: ≥220, M/L/XL: ≥230.
    Width (mm): Blue/Green Color: XS:70±10; S:80±10; M:95±10; L:110±10; XL:120±10; Black Color: S:80±10; M:95±10; L:110±10; XL:120±10.
    Thickness (mm): Finger: ≥0.05, Palm: ≥0.05.Length: >230 mm (for all sizes, exceeding the minimums).
    Width:
    • Green Color: XS:7376; S:8084; M:9599; L:108111; XL:114~117.
    • Blue Color: XS:7275; S:8590; M:9298; L:108111; XL:110~119.
    • Black Color: S:8290; M:9397; L:108111; XL:114116.
      Thickness (mm):
    • Green: Finger: 0.14-0.15, Palm: 0.12-0.14.
    • Blue: Finger: 0.12-0.13, Palm: 0.11-0.12.
    • Black: Finger: 0.15-0.16, Palm: 0.12-0.13.
      Result: Pass for all. |
      | ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Level of 2.5 for freedom from holes). | Green: 0/125 leaks; Blue: 0/125 leaks; Black: 0/125 leaks.
      Result: Pass for all. |
      | ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124
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