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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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The powder free light yellow stretch 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. It has light yellow color and is sold as non sterile.

Powder free light-yellow stretch vinyl patient examination gloves 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. They have light yellow color.

The provided document describes the acceptance criteria and a study demonstrating that the "Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves" meet these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against several ASTM and ISO standards. The table below summarizes these.

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., number of gloves tested for pinholes, skin irritation, etc.). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." The data provenance is from Wealth On (Jiangsu) Co., Ltd, China, and the tests were likely conducted prospectively as part of the 510(k) submission for the new device.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective, standardized testing methods (ASTM, ISO) rather than expert consensus on subjective evaluations.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective and based on established physical and biological testing procedures, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This is a submission for a medical device (patient examination gloves), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant.

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

This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is for the physical and biological properties of the gloves themselves.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements and results obtained through standardized laboratory testing according to ASTM and ISO standards for physical properties and biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such devices would be the manufacturing process itself, ensuring consistency and quality control.

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

This information is not applicable. There is no "training set" in the context of this device. The standards (ASTM, ISO) themselves define the acceptable performance characteristics, and the manufacturing process aims to consistently produce gloves that meet these predefined criteria.

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The powder free 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. It is sold as non sterile.

Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.

The provided text describes the acceptance criteria and the study for a medical device: "Powder Free Vinyl Patient Examination Gloves."

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 specify the exact sample size used for each test. It states that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These consensus standards (ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10) would dictate the specific sampling plans.

The data provenance is from Wealth On (Jiangsu) Co., Ltd, located in Yancheng, Jiangsu Province, China. The study is a retrospective evaluation performed on the manufactured gloves against established standards.

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

This information is not provided in the document. For these types of physical and biocompatibility tests on medical gloves, "ground truth" is typically established by adherence to the specifications and methods outlined in the referenced consensus standards, rather than requiring individual expert consensus. The standards themselves define what constitutes a pass or fail.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided as the evaluation is based on objective measurements against engineering and material standards, not subjective assessments 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 relevant for diagnostic devices that involve human interpretation of images or other data. For physical examination gloves, such a study is not applicable.

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 product (gloves), not a software algorithm, so this type of study is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on consensus standards and laboratory testing protocols. The performance criteria are defined by established standards such as ASTM International standards (D5250-06, D5151-06, D6124-06) and ISO standards (ISO 10993-10). These standards provide the objective benchmarks for what constitutes acceptable performance for patient examination gloves.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a physical product, not an AI/ML algorithm that requires a "training set." The testing performed is to assess the manufactured product's compliance with established performance criteria.

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

This information is not applicable/not provided as there is no training set for this device.

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