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510(k) Data Aggregation

    K Number
    K142703
    Device Name
    Powder-free PVC Vinyl Exam Gloves
    Manufacturer
    Hebei Grandeast Plastic Products Co., Ltd.
    Date Cleared
    2015-01-15

    (115 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K130733
    Predicate For
    K151754,K170735,K171317,K173078
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

    Device Description

    The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

    AI/ML Overview

    This document is a 510(k) summary for Hebei Grandeast Plastic Products Co., Ltd.'s Powder-free PVC Vinyl Exam Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

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

    Test ParameterAcceptance Criteria (Proposed Device)Reported Device Performance (Proposed Device)Acceptance Criteria (Predicate Device)Reported Device Performance (Predicate Device)
    Dimensions
    LengthComply with ASTM D5250-06 (Reapproved 2011): > 230 mmCompliesComply with ASTM D5250-06 (Reapproved 2011): > 230 mmComplies
    Width (S)Comply with ASTM D5250-06 (Reapproved 2011): 85±5mmCompliesComply with ASTM D5250-06 (Reapproved 2011): 85±5mmComplies
    Width (M)Comply with ASTM D5250-06 (Reapproved 2011): 95±5mmCompliesComply with ASTM D5250-06 (Reapproved 2011): 95±5mmComplies
    Width (L)Comply with ASTM D5250-06 (Reapproved 2011): 105±5mmCompliesComply with ASTM D5250-06 (Reapproved 2011): 105±5mmComplies
    Width (XL)Comply with ASTM D5250-06 (Reapproved 2011): 115±5mmCompliesComply with ASTM D5250-06 (Reapproved 2011): 115±5mmComplies
    Thickness (Palm)Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mmCompliesComply with ASTM D5250-06 (Reapproved 2011): > 0.08mmComplies
    Thickness (Finger-tip)Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mmCompliesComply with ASTM D5250-06 (Reapproved 2011): > 0.05mmComplies
    Physical Properties
    Tensile StrengthBefore aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011)CompliesBefore aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011)Complies
    Ultimate ElongationBefore aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011)CompliesBefore aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011)Complies
    Freedom from HolesComply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011)CompliesComply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011)Complies
    Residue Powder0.6 +/- 0.1 mg per glove. Comply with ASTM D5250-06 (Reapproved 2011)Complies
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