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510(k) Data Aggregation

    K Number
    K061192
    Device Name
    BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Date Cleared
    2006-05-23

    (25 days)

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free , Poly, Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a(2005).

    AI/ML Overview

    The provided text describes a 510(k) submission for medical examination gloves and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about the performance of a diagnostic AI device or a study designed to evaluate its acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert ground truth, adjudication methods, or MRMC studies is not applicable to this document.

    However, I can extract the acceptance criteria and documented performance for the medical device described (a glove), as well as details about the non-clinical tests performed.

    Acceptance Criteria and Reported Device Performance (for the glove device)

    Acceptance Criteria / TestReported Device Performance / Compliance
    Physical and Dimensions Testing (ASTM D-6319-00a(2005))All testing meets requirements; Inspection level S-2, AQL 4.0.
    Pinhole Test (FDA 1000 ml. Water Fill Test)Meets requirements; Samplings of AQL 2.5, inspection level G-1. Conforms fully to FDA pinhole requirements.
    Primary Skin IrritationNo primary skin irritant reactions.
    Skin Sensitization (Allergic Contact Dermatitis)No sensitization reactions.
    Residual Powder Test (ASTM D-6124-06)Meets "powder-free" claims (contains no more than 2 mg powder per glove).
    Biocompatibility RequirementsMeets biocompatibility requirements (as shown by data in Section 7).
    Labeling ClaimsMeets labeling claims; No special labeling claims are made, and gloves are not claimed as hypoallergenic.
    Overall Conformity to StandardsConforms fully to ASTM D-6319-00a(2005) standard as well as applicable 21 CFR references. No safety/efficacy issues or new claims from the "substantial equivalence" products cited.

    Study Information (Non-Clinical Tests for the Glove Device)

    • Sample size used for the test set and the data provenance:
      • Physical/Dimensions testing: Inspection level S-2, AQL 4.0. (Specific sample size not provided, but implies a statistical sampling plan based on AQL).
      • Pinhole (Water Fill Test): AQL 2.5, inspection level G-1. (Specific sample size not provided, but implies a statistical sampling plan based on AQL).
      • Primary Skin Irritation and Skin Sensitization: No details on sample size or provenance.
      • Residual Powder Test: No details on sample size or provenance.
      • Data Provenance: Not explicitly stated, but assumed to be from manufacturing runs of the Syntex Healthcare Products Co., Ltd. gloves.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical tests, not diagnostic interpretations.
    • Adjudication method: Not applicable.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic AI device.
    • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.
    • The type of ground truth used:
      • Physical/Dimensions Testing: Predetermined specifications outlined in ASTM D-6319-00a(2005).
      • Pinhole Testing: Absence of water leakage under specific pressure/volume conditions per FDA 1000 ml Water Fill Test.
      • Biocompatibility (Skin Irritation/Sensitization): Observation of skin reactions in test subjects to determine irritant or sensitizing properties.
      • Residual Powder: Quantitative measurement of powder content against the 2 mg per glove limit specified in ASTM D-6124-06.
    • The sample size for the training set: Not applicable. This is not an AI/machine learning device.
    • How the ground truth for the training set was established: Not applicable.
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