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Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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 Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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., how many gloves were tested for pinholes, physical properties, etc.). However, it refers to compliance with established standards (ASTM D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10). These standards would define the required sample sizes for testing.

The data provenance is from non-clinical testing conducted by the manufacturer, Suqian Ruijiang Medical Supplies Co., Ltd. The document does not specify the country of origin of the raw data, but the manufacturer is based in Suqian, Jiangsu, China. The testing described is retrospective in the sense that the results were generated prior to the 510(k) submission to demonstrate compliance with existing standards.

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

This information is not applicable to this submission. The "ground truth" for this Class I medical device (patient examination gloves) is established by adherence to recognized regulatory standards and specifications, rather than expert consensus on complex diagnostic interpretations. The standards themselves define the acceptable parameters for glove performance.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or other subjective assessments. For this device, the "judgement" is determined by whether the test results meet the objective, quantitative criteria outlined in the referenced ASTM standards and FDA regulations.

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 information is not applicable. This submission is for a basic medical device (examination gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

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

This information is not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on established regulatory standards and objective test methods. Specifically:

• ASTM D 5250-06 e1: Standard for Vinyl Patient Examination Gloves. This standard specifies requirements for dimensions, physical properties (tensile strength, elongation), and other performance characteristics.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves. This standard dictates the acceptable levels of powder residue.
• 21 CFR 800.20: This FDA regulation pertains to the freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. This standard sets the criteria for biocompatibility testing.

The "ground truth" is that the device must meet the specifications and pass the tests outlined in these standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved here.

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

This information is not applicable for the same reasons as #8.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

This 510(k) submission describes the Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., details on training set, experts, MRMC studies) are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size for a given lot is not provided but would be determined by the AQL (Acceptable Quality Limit) and inspection level. This is a factory quality control measure, so the data provenance is from the manufacturer's internal testing in China (Shijiazhuang, Hebei, China). This is retrospective testing of manufactured products.
• Pinhole / Water Fill Test: Samplings of AQL 2.5, inspection level I. Similar to above, the specific sample size for a given lot is not provided. Data provenance is from the manufacturer's internal testing in China, retrospective.
• Primary Skin Irritation and Skin Sensitization: The document states that testing was conducted but does not specify the sample size or the data provenance beyond "with results showing." It is typically done on human subjects or animal models as per relevant ISO standards.
• Residual Powder Test: Not specified beyond "at finished inspection."

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

Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described is primarily for engineering performance and biocompatibility, not for diagnostic or therapeutic efficacy requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards (ASTM, FDA) for physical properties, chemical residue, and biological reactivity, not subjective interpretations 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 device is a physical barrier (glove), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Physical and Dimensions Testing: The ground truth is defined by the specifications in ASTM D-5250-00E4.
• Pinhole / Water Leak Test: The ground truth is defined by the FDA 1000 ml. Water Fill Test requirements.
• Primary Skin Irritation and Skin Sensitization: The ground truth is established by standard toxicological assessment protocols, typically involving expert interpretation of skin reactions.
• Residual Powder Test: The ground truth is defined by the maximum allowable powder content (2 mg/glove) as per ASTM D6124-06.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

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 5250-00-4

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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