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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided K051935 Premarket Notification [510(k)] Summary pertains to "Powder Free Vinyl Patient Examination Gloves, White (non-colored)". This device is a medical glove, and the acceptance criteria and study detailed are for demonstrating its compliance with relevant standards and safety.

Here's a 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 specific sample sizes used for each test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). It refers to meeting the requirements of the standards (ASTM D 5250-00c4, 21 CFR 800.20, D6124-01, and ISO10993-10). These standards would define the required sample sizes for such testing.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a specific country of origin for the data (beyond the submitter's address being in China). However, generally, performance testing for medical devices like gloves is conducted prospectively on manufactured samples.

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

This information is not applicable in the context of this device and its testing. Performance criteria for medical gloves are based on established engineering and safety standards (e.g., ASTM, FDA regulations). There is no "ground truth" established by human experts in the same way it would be for an AI diagnostic device. The "ground truth" is defined by the objective measurements and pass/fail criteria of the specified standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the tests are objective measurements against established standards, not subjective interpretations requiring adjudication.

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 specifically relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance to assess the AI's impact on human performance. For a patient examination glove, such a study is not relevant.

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

No, a standalone study was not done. This concept is also primarily applicable to diagnostic algorithms. The "device" in this case is a physical product (gloves) whose performance is assessed through laboratory testing against physical, chemical, and biological standards, not through an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on established objective criteria defined within recognized standards and regulations. These include:

• ASTM standard D 5250-00c4: Specifies requirements for dimensions, physical properties, and powder residue.
• 21 CFR 800.20: Relates to freedom from pinholes (waterleak test AQL).
• ASTM D6124-01: Also concerns powder residue.
• ISO10993-10: Addresses biocompatibility (primary skin irritation and dermal sensitization).

Essentially, the ground truth is the compliance with these pre-defined, measurable specifications.

8. The Sample Size for the Training Set:

This device does not have a "training set" in the typical sense of machine learning or AI. Performance testing is done on manufactured samples according to the specifications of the referenced standards. There is no algorithm being "trained."

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

As there is no training set, this question is not applicable.

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided is standard for this type of device and does not involve complex AI algorithms or detailed clinical studies in the way you might expect for an AI-powered diagnostic tool. Therefore, many of your requested items, such as expert adjudication, MRMC studies, and detailed training set information, are not applicable in this context.

Here's an analysis based on the provided document:

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

2- Sample size used for the test set and the data provenance

The document indicates that the device meets the specified ASTM standards and FDA regulations, which involve testing batches of gloves to ensure compliance. However, it does not specify explicit sample sizes for the "test set" in the context of a software or AI device. The testing related to manufacturing quality (pinholes, dimensions, physical properties, powder residual) is typically done on a statistically representative sample from each production lot, as per the respective standards (e.g., AQL levels for pinholes).

• Sample Size: Not explicitly stated for each test, but implied to be statistically significant samples as required by the referenced ASTM standards and 21 CFR 800.20 for manufacturing quality control.
• Data Provenance: The tests are conducted by the manufacturer, HEBEI MANFUL IMPORT & EXPORT CO., LTD, presumably in their facilities in P.R. CHINA, to demonstrate compliance with US standards (ASTM, FDA). This is a prospective evaluation of manufactured product batches.

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

This type of examination glove does not involve expert interpretation or ground truth establishment in the way AI diagnostics do. The "ground truth" for these tests are objective measurements against established physical and chemical standards.

• Number of Experts: Not applicable. The "ground truth" is defined by the objective measurement criteria of the ASTM and FDA standards.
• Qualifications of Experts: Not applicable in the context of human interpretation. Quality control technicians, chemists, and engineers with expertise in materials testing perform the measurements.

4- Adjudication method for the test set

Not applicable. Testing involves objective measurements (e.g., tensile strength, elongation, physical dimensions, water leak test for pinholes, chemical analysis for powder residue, and biological assays for biocompatibility). There is no subjective interpretation requiring adjudication.

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 physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device.

7- The type of ground truth used

The ground truth used for demonstrating compliance is based on:

• Objective Measurement Data: Physical dimensions, tensile strength, elongation, freedom from pinholes (water leak test AQL), and powder residual measured against an absolute standard.
• Biological Assay Results: Results from standardized in vivo tests for primary skin irritation and dermal sensitization, which are objective pass/fail criteria.

8- The sample size for the training set

Not applicable. There is no software or AI algorithm in this device that requires a training set.

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

Not applicable. There is no software or AI algorithm in this device that requires a training set.

In summary: The provided document describes a medical device that undergoes quality control testing to meet established industry and regulatory standards. It is not an AI-powered device, so many of the questions asked in the prompt, which are typically relevant for AI/ML device evaluations, do not apply here. The "study" proving the device meets acceptance criteria refers to manufacturing quality control and biocompatibility testing against defined industry standards (ASTM) and FDA regulations.

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