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The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.

Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.

The provided text describes the performance of "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)" (or other clients private labeling) to demonstrate substantial equivalence to predicate devices, rather than a device that employs AI or requires complex studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this type of device submission.

The acceptance criteria and device performance are based on meeting established consensus standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria consisted of non-clinical tests conducted following the recommended procedures outlined in the respective consensus standards. The summary explicitly states: "Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling), manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd" met all relevant requirements in the test standards, and are comparable to the predicate device."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. For medical devices like examination gloves, testing a statistically representative sample size according to the relevant ASTM or ISO standards is implied.
• Data Provenance: The tests were conducted by the manufacturer, Wealth On (Jiangsu) Co., Ltd, located in Jiangsu Province, China. The data would therefore be prospective from the manufacturer's testing process.

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

This is not applicable as the "ground truth" for this device is determined by objective, standardized physical and biocompatibility tests (e.g., measuring dimensions, tensile strength, freedom from pinholes, or observing skin reactions) as defined by the ASTM and ISO standards, not by expert consensus on interpretation.

4. Adjudication method for the test set:

Not applicable. Performance is determined by objective technical measurements against defined standard thresholds, not by human adjudication of ambiguous findings.

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 not an AI-assisted device, nor does it involve human readers or diagnostic interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth is based on established consensus standards (ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10) which define the physical, performance, and biocompatibility requirements for patient examination gloves.

8. The sample size for the training set:

Not applicable. This device does not have a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not have a "training set" or a ground truth established for it in that manner. The "ground truth" for its performance is determined by adherence to the aforementioned objective industry standards.

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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.

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