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510(k) Data Aggregation

    K Number
    K211586
    Device Name
    Nitrile Examination Gloves (Blue, Violet)
    Manufacturer
    Lyncmed Medical Technology (Beijing) Co., Ltd.
    Date Cleared
    2021-11-01

    (161 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K150340
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.

    AI/ML Overview

    This document describes the performance testing for Nitrile Examination Gloves (Blue, Violet). Here's a breakdown of the acceptance criteria and study details:

    Acceptance Criteria and Reported Device Performance

    Device: Nitrile Examination Gloves (Blue, Violet)
    Purpose: Non-sterile disposable device worn to prevent contamination between patient and examiner.

    Test MethodPurposeAcceptance CriteriaReported Device Performance
    ASTM D5151Testing for Freedom from HolesFreedom from holes AQL 2.5Blue Color: No water leakage inspected from 200 samplesViolet Color: No water leakage inspected from 200 samples
    ASTM D6124Determine the powder residue for powder free gloves< 2.0 mg per gloveBlue Color: Residual Powder: Average 0.05 – 0.10 mgViolet Color: Residual Powder: Average 0.04 – 0.10 mg
    ASTM D412, ASTM D573Testing for Physical Property CharacteristicsBefore Aging: Tensile Strength: 14 MPa min., Ultimate Elongation: 500% min.After Aging: Tensile Strength: 14 MPa min., Ultimate Elongation: 400% min.Blue Color:- XS: Before Aging: Tensile Strength: ≥ 31.1 MPa, Ultimate Elongation: ≥ 505 %; After Aging: Tensile Strength: ≥ 30.1 MPa, Ultimate Elongation: ≥ 460%.- S: Before Aging: Tensile Strength: ≥ 31.3 MPa, Ultimate Elongation: ≥ 507 %; After Aging: Tensile Strength: ≥ 32.1 MPa, Ultimate Elongation: ≥ 457%.- M: Before Aging: Tensile Strength: ≥ 31.2 MPa, Ultimate Elongation: ≥ 506 %; After Aging: Tensile Strength: ≥ 28.2 MPa, Ultimate Elongation: ≥ 447%.- L: Before Aging: Tensile Strength: ≥ 30.9 MPa, Ultimate Elongation: ≥ 506 %; After Aging: Tensile Strength: ≥ 27.9 MPa, Ultimate Elongation: ≥ 426%.- XL: Before Aging: Tensile Strength: ≥ 31.0 MPa, Ultimate Elongation: ≥ 508 %; After Aging: Tensile Strength: ≥ 25.1 MPa, Ultimate Elongation: ≥ 408%. Violet Color:- XS: Before Aging: Tensile Strength: ≥ 24.1 MPa, Ultimate Elongation: ≥ 510 %; After Aging: Tensile Strength: ≥ 28.6 MPa, Ultimate Elongation: ≥ 408%. - S: Before Aging: Tensile Strength: ≥ 26.5 MPa, Ultimate Elongation: ≥ 515 %; After Aging: Tensile Strength: ≥ 29.8 MPa, Ultimate Elongation: ≥ 436%.- M: Before Aging: Tensile Strength: ≥ 26.3 MPa, Ultimate Elongation: ≥ 515 %; After Aging: Tensile Strength: ≥ 26.7 MPa, Ultimate Elongation: ≥ 462%.- L: Before Aging: Tensile Strength: ≥ 25.9 MPa, Ultimate Elongation: ≥ 510 %; After Aging: Tensile Strength: ≥ 25.6 MPa, Ultimate Elongation: ≥ 457%.- XL: Before Aging: Tensile Strength: ≥ 26.5 MPa, Ultimate Elongation: ≥ 517 %; After Aging: Tensile Strength: ≥ 25.0 MPa, Ultimate Elongation: ≥ 453%.
    ASTM D412, ASTM D3767Testing for Physical Dimensions SpecificationLength: 220 mm min. for size (XS, S); 230 mm min. for size (M, L, XL); Width: 70±10 mm for XS; 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL; Finger Thickness: ≥0.05 mm; Palm Thickness: ≥0.05 mm. All acceptance criteria meet ASTM D6319.Blue Color:- XS: Length: ≥ 225mm; Width: 70±8 (77-78) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- S: Length: ≥ 246mm; Width: 80±7 (86-87) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- M: Length: ≥ 240 mm; Width: 95±4 (98-99) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- L: Length: ≥ 243mm; Width: 110±3 (107-108) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- XL: Length: ≥ 243mm; Width: 120±6 (114-116) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.Violet Color:- XS: Length: ≥ 225mm; Width: 70±8 (77-78) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- S: Length: ≥ 246mm; Width: 80±7 (86-87) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- M: Length: ≥ 240 mm; Width: 95±4 (98-99) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- L: Length: ≥ 242mm; Width: 110±3 (107-108) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- XL: Length: ≥ 243mm; Width: 120±6 (114-116) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.
    ISO 10993-11Evaluate systemic toxicity for biocompatibilityThe test article showed no evidence of systemic toxicity potential from the extract.The test article showed no evidence of systemic toxicity from the extract.
    ISO 10993-10Evaluate irritation for biocompatibility; Evaluate sensitization for biocompatibilityThe response of the test article extract is negligible. The test article showed no evidence of causing delayed dermal contact sensitization.The test result showed that the response of the test article extract was categorized as negligible under the test condition. The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

    Study Information:

    Based on the provided document, the device in question is Nitrile Examination Gloves, and the studies performed are non-clinical performance tests for medical gloves. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to established ASTM and ISO standards for physical properties and biocompatibility.

    Here's the breakdown of the requested information, where applicable:

    1. A table of acceptance criteria and the reported device performance: This is provided in the comprehensive table above.

    2. Sample size used for the test set and the data provenance:

      • Freedom from holes (ASTM D5151): 200 samples were inspected for both Blue and Violet colored gloves.
      • Other tests (Physical properties, Dimensions, Biocompatibility): The exact sample sizes for these tests are not explicitly stated in the provided text, beyond the "200 samples" for the pinhole test. However, it's inferred that sufficient samples were tested to meet the requirements of the respective ASTM and ISO standards.
      • Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, these are typically pre-market, prospective tests conducted by the manufacturer or accredited labs.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • For performance testing of medical gloves, "ground truth" is established by adherence to specified scientific and engineering standards (ASTM and ISO). This does not typically involve human expert consensus in the way an AI diagnostic algorithm for medical imaging would. The expertise lies in the certified laboratories and personnel performing the standardized tests according to the laid-out protocols. The document does not specify the number or qualifications of experts involved in setting the ground truth beyond conforming to the cited standards.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not applicable for this type of performance testing. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., medical image interpretation) to establish ground truth for algorithm training or evaluation. Here, the ground truth is defined by objective physical and chemical testing standards.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not applicable. This is a submission for a medical device (nitrile gloves), not an AI algorithm for diagnosis or interpretation. Therefore, no MRMC study or AI assistance evaluation would be performed.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This is for a non-diagnostic physical medical device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth is based on established industry standards and test methodologies for physical properties, dimensions, and biocompatibility, as defined by ASTM International and ISO. This is a form of objective, standardized measurement, not expert consensus or clinical outcomes data in the traditional sense for diagnostic devices.

    8. The sample size for the training set:

      • Not applicable. This device is not an AI algorithm that requires a "training set." The listed tests are for product validation, not algorithm development.

    9. How the ground truth for the training set was established:

      • Not applicable, as there is no training set for this type of device submission.
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