Search Results

Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, 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 a sample size for the test set. It mentions "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM PRO10002 10 Fowdered - viryl patient channel pro 21 CFR 800.20 and ISO10993-10," implying that these standards' specified testing methodologies (which would include sample sizes) were followed. However, the specific numbers are not provided.

The data provenance is not explicitly mentioned but based on the submitter's address (CHINA) and the general nature of compliance testing for medical devices, it is highly likely the data was generated in China and is prospective (i.e., new testing conducted for the submission).

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

This information is not provided in the document. The standards (ASTM, CFR, ISO) would define the methodology for establishing conformity, which might involve expert assessment, but the document does not elaborate on the expert involvement or their qualifications for the specific tests.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The tests appear to be objective measurements against defined standards rather than interpretations requiring adjudication among multiple experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This device is a patient examination glove, which does not involve human interpretation in the same way.

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

Yes, a standalone performance evaluation was done. The device's performance was measured directly against established standards (ASTM, 21 CFR, ISO) for its physical, chemical, and biological properties. This testing does not involve human-in-the-loop interaction for performance evaluation; it's about the inherent qualities of the glove itself.

7. Type of Ground Truth Used:

The ground truth used is primarily objective measurements against established industry and regulatory standards. These standards define acceptable ranges or thresholds for characteristics like dimensions, physical properties, pinholes, and powder amount. For biocompatibility, the ground truth is derived from the results of standardized animal testing (rabbit irritation, guinea pig sensitization).

8. Sample Size for the Training Set:

This information is not applicable to this device and its evaluation methods. Training sets are relevant for machine learning algorithms. The evaluation of a patient examination glove relies on physical, chemical, and biological testing against predefined standards, not on algorithms trained on data.

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

This information is not applicable as there is no training set for this type of device.

Ask a specific question about this device

Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and the study conducted for "Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)".

Here's the breakdown of the requested information:

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 sample sizes used for each specific test (e.g., dimension, pinholes, physical properties, powder residual, biocompatibility). However, it implies that the tests were conducted according to the respective ASTM standards, 21 CFR 800.20, and ISO10993-10, which would inherently specify sample sizes and methodologies.

The data provenance is from China, as the submitter is SHIJIAZHUANG CENTURY PLASTIC CO., LTD with an address in China. The study appears to be prospective in nature, as new testing was conducted specifically for this 510(k) submission to demonstrate compliance with the referenced standards.

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

This information is not applicable to this type of device and study. The "ground truth" for medical gloves is established by objective measurements against recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed on the gloves (e.g., physical properties, pinholes, powder residual, biocompatibility) involve objective measurements and established laboratory procedures, not subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a physical medical glove.

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

N/A (Not Applicable). This question pertains to AI/algorithm performance. The device is a physical medical glove, and no algorithm or AI component is involved.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and laboratory test results that demonstrate compliance with established, recognized industry standards and regulations. These include:

• ASTM standard D 5250-06 (for dimensions, physical properties, powder residual)
• ASTM standard D 6124-01 (for powder residual)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical device like a glove.

Ask a specific question about this device