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510(k) Data Aggregation

    K Number
    K011407
    Device Name
    LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
    Manufacturer
    SEMPERMED USA, INC.
    Date Cleared
    2001-09-11

    (145 days)

    Product Code
    LYY
    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
    Device Description
    AI/ML Overview
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    K Number
    K011749
    Device Name
    LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
    Manufacturer
    SEMPERMED USA, INC.
    Date Cleared
    2001-08-22

    (83 days)

    Product Code
    LYY,80L
    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 examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

    Device Description

    Latex Patient Examination glove , Powder Glove (Single side polymer coated) , non sterile 200 micrograms or less of total water extractable protein per gram

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the "Latex Patient Examination Glove, Powder Glove (Single side polymer coated)".

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceStudy Type
    Dimensions meet ASTM D3578-00Meets ASTM D3578-00Internal Testing (implied)
    Physical Properties meet ASTM D3578-00Meets ASTM D3578-00Internal Testing (implied)
    Protein content 200 ug/dm2 or less (recommended in ASTM D3578-00)200 micrograms or less of total water extractable protein per gram (stated as meeting claims)Internal Testing (implied)
    Freedom from pinholes meet ASTM D3578-00Meets ASTM D3578-00Internal Testing (implied)
    Freedom from pinholes meet ASTM D5151Meets ASTM D5151Internal Testing (implied)
    Not a primary dermal irritant (16 CFR 1500.41)"This test article is not a primary dermal irritant"Primary Dermal Irritation in Rabbits
    Not a sensitizer in guinea pigs"This test article is not a sensitizer in guinea pigs"Guinea Pig Sensitization (Buehler)

    2. Sample Size Used for the Test Set and Data Provenance

    The provided text does not explicitly state the sample sizes used for the various tests (Dimensions, Physical Properties, Protein content, Freedom from pinholes, Dermal Irritation, Sensitization).

    The data provenance is internal to the manufacturer, Siam Sempermed Corp., Ltd., and a third-party testing laboratory, Consumer Product Testing Co., for irritation and sensitization. The location of the manufacturing and the contact person for the company are in Thailand. The data appears to be retrospective as it is presented as conclusions of completed tests.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This type of information is not applicable to the testing performed for this device. The acceptance criteria are based on established ASTM standards and Federal Hazardous Substances Act Regulations, which define objective measures rather than requiring expert consensus for ground truth.

    4. Adjudication Method for the Test Set

    This information is not applicable as the evaluation is based on objective measurements against defined standards, not on subjective assessments requiring adjudication among multiple experts.

    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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical glove, a physical product, and not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No, a standalone algorithm-only performance study was not done. This device is a physical medical glove and does not involve any algorithms or AI components.

    7. The Type of Ground Truth Used

    The ground truth used for this device is based on:

    • Established industry standards: ASTM D3578-00 and ASTM D5151 for physical properties, dimensions, protein content, and freedom from pinholes.
    • Regulatory criteria: Federal Hazardous Substances Act Regulation (16 CFR 1500.41) for primary dermal irritation and general principles of toxicology for sensitization.

    8. The Sample Size for the Training Set

    This information is not applicable. This device is a manufactured physical product, not a machine learning model, and therefore does not have a "training set" in the context of AI or algorithms.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable for the same reasons as point 8.

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