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The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

The provided text details the 510(k) summary for the "Vinyl Patient Examination Glove (Yellow)" (K173580) and compares it to a predicate device (K163168). The information specifically relates to the technical specifications and performance of the examination gloves, rather than an AI/ML device or a medical imaging system. Therefore, many of the requested categories in the prompt regarding AI/ML device evaluation are not applicable.

Here's an analysis based on the available information:

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

The acceptance criteria for the Vinyl Patient Examination Glove (Yellow) are primarily based on established industry standards and specific physical and biological properties. The reported device performance is presented in comparison to a predicate device and adherence to these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies (as it states "No clinical study is included in this submission"). For non-clinical tests like physical properties and freedom from holes, the standards (e.g., ISO 2859-1 for sampling) outline the sampling procedures, but specific sample sizes used in this submission are not explicitly stated. The manufacturer is "NATURE MEDICAL PRODUCTS CO., LTD." in Hebei, China, which suggests the tests were likely conducted in China. These non-clinical tests would be considered prospective for the device being evaluated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a Vinyl Patient Examination Glove, not an AI/ML device requiring expert medical interpretation for ground truth. The "ground truth" for these types of devices is based on established laboratory testing and adherence to recognized performance standards (e.g., ASTM, ISO standards) for physical and biological properties.

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

This is not applicable since this document relates to a physical medical device (examination gloves) and not a diagnostic system requiring human interpretation or adjudication for ground truth.

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

This is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an examination glove.

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

The "ground truth" for this device is based on:

• Industry Standards: Compliance with established physical and chemical property requirements outlined in standards such as ASTM D5250, ASTM D5151, ASTM D6124.
• Biocompatibility Testing: Results from in vitro and in vivo tests (ISO 10993-5, ISO 10993-10) determining irritation, sensitization, and cytotoxicity.
• Manufacturing Specifications: Adherence to the manufacturer's own design and material specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device.

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

This is not applicable as there is no training set for an AI/ML model.

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The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for biocompatibility). However, it indicates compliance with recognized standards that prescribe sampling methods.

• ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard outlines sampling procedures to determine freedom from holes.
• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection: This standard was used for sampling procedures.

The data provenance is from non-clinical laboratory testing performed by or for Yurun Glove Co., Ltd. in China. The study is prospective in the sense that tests were conducted specifically for this submission.

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

Not applicable. The ground truth for this device (a medical glove) is established through adherence to recognized international and national consensus standards (e.g., ASTM, ISO) for physical properties, barrier integrity, and biocompatibility, rather than expert consensus on interpretive data like medical images. The "experts" would be the certified laboratories and personnel performing the standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is measured against objective, standardized laboratory tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically performed for AI/CAD devices involving interpretation of medical images or data by human readers. This device is a medical glove, and its performance is assessed via non-clinical laboratory tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This concept is not applicable to a physical medical device like a glove. The device itself is not an algorithm.

7. Type of Ground Truth Used

The ground truth is based on:

• Established consensus standards: Such as ASTM D5250 for Poly(vinyl chloride) Gloves for Medical Application, ASTM D6124 for Residual Powder, ASTM D5151 for Detection of Holes, ISO 10993-10 for Irritation and Sensitization, and ISO 10993-5 for Cytotoxicity. These standards define the acceptable performance parameters.
• Objective laboratory measurements: The device's physical properties (e.g., tensile strength, elongation, thickness, freedom from holes, powder content) and biocompatibility are measured against the specifications outlined in these standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI/machine learning requiring a training set.

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

Not applicable, as there is no training set for this device.

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