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Disposable Vinyl Examination Gloves 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.

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Disposable Vinyl Examination Gloves 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 subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

Additional Information (As applicable to this type of device)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Physical Performance Testing: For "Freedom from holes," the reported sample size was "80 of 80 passed." Other physical tests (dimensions, physical properties, residual powder) often rely on samples drawn from manufacturing lots according to the specified ASTM standards, but specific sample sizes for each characteristic are not explicitly stated beyond what's implied by the standards.
• Biocompatibility Testing: The standards (ISO 10993 series) define the protocols and sample sizes for these tests, but specific numbers are not provided in this summary.
• Data Provenance: Not explicitly stated, but assumed to be from Anqing Pukang Medical Technology Co., LTD. in China, where the device is manufactured. The tests are prospective, as they are part of the premarket notification process for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory protocols, not by expert interpretation in a clinical context. The results are quantitative measurements or observations of biological reactions performed by qualified lab personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. This concept is primarily relevant to studies involving human subjective evaluation or complex diagnostic interpretation where disputes need resolution. Performance testing for gloves involves objective measurements or standardized biological assays.

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

• N/A. This is a physical device, not an AI/software device. No human reader studies are relevant.

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

• N/A. This is a physical device, not an AI/software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For physical properties and dimensions: Standards-based objective measurements.
• For freedom from holes: Pass/fail criteria based on water leak test per ASTM standards.
• For residual powder: Quantitative measurement per ASTM standards.
• For biocompatibility: Laboratory assays and observations of biological reactions (e.g., skin irritation, sensitization, cytotoxicity) as defined by ISO 10993 series standards.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/software device. No training set is used.

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

• N/A. This is a physical device, not an AI/software device. No training set or associated ground truth is relevant.

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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • Watertightness Test (ASTM D5151): The result 0/125 / Pass indicates that out of 125 units tested, 0 failed, suggesting a sample size of 125 for this specific test.
  • For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested for each criterion. It reports ranges for dimensions and physical properties, which usually implies multiple samples were tested, but the exact count is not given.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. The manufacturer is located in Jiujiang City, Jiangxi, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this device is a physical examination glove, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is established by direct measurement and standardized test methods (e.g., ASTM and ISO standards) and their inherent acceptance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as this device is a physical examination glove. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers, needing a tie-breaker. The tests for this device involve objective measurements against established standards.

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 as this device is a physical examination glove and not an AI-assisted diagnostic tool.

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

This information is not applicable as this device is a physical examination glove and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements against established industry standards, specifically ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, and ISO 10993-10. These standards define acceptable physical properties, freedom from holes, powder content, and biocompatibility, which are directly measured and compared.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set."

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

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set" or ground truth for such a set.

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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly mentions "0/125 / Pass" for the ASTM D5151 Watertightness Test, indicating a sample size of 125 for this test. For other "Pass" results, the exact sample sizes are not explicitly stated, but the tests are typically performed on a statistically relevant number of samples to demonstrate compliance with the ASTM/ISO standards.
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer. The company is Anhui Bytech Medical Supplies Co., Ltd., located in Anhui Province, China. The data is from the manufacturer's internal testing as part of their premarket notification. The document indicates these are "non-clinical tests."

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

• Not Applicable. This is a medical device 510(k) submission for examination gloves, which are low-risk devices. The "ground truth" for proving the device meets acceptance criteria comes from standardized laboratory bench testing (e.g., measuring physical properties, mechanical strength, and biocompatibility), not from expert interpretation of medical images or clinical outcomes. Therefore, no medical experts were involved in establishing "ground truth" for the performance tests.

4. Adjudication Method for the Test Set

• Not Applicable. As the "ground truth" is established via objective physical and chemical measurements (bench testing) according to international standards (ASTM, ISO), there is no need for expert adjudication. The results are quantitative and directly compared to pre-defined acceptance criteria.

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

• Not Applicable. This device is an examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are relevant for evaluating the impact of AI on human readers' performance in tasks like image interpretation, which is not pertinent to this device.

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

• Not Applicable. There is no AI algorithm involved with this device; it is a physical product (gloves).

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, quantitative measurements from standardized laboratory tests according to recognized international consensus standards (ASTM and ISO). Examples include:
  • Direct measurement of dimensions (length, width, thickness).
  • Quantification of tensile strength and ultimate elongation.
  • Detection of holes using a water integrity test.
  • Measurement of residual powder content.
  • Biological performance testing (cytotoxicity, irritation, sensitization) in vitro, which involves observing cellular responses under controlled lab conditions.

8. The Sample Size for the Training Set

• Not Applicable. This submission is for a physical medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself involves quality control and process validation, which might involve sample testing, but this is distinct from "training data" for an algorithm.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided document.

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The Disposable Vinyl Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Disposable Vinyl Examination Gloves

The provided document is an FDA 510(k) clearance letter for "Disposable Vinyl Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria, as it pertains to medical gloves, not a diagnostic or AI-powered device.

The questions in the prompt are typical for evaluating a new diagnostic or AI-driven medical device submission, which would involve performance metrics like sensitivity, specificity, accuracy, and detailed study methodologies. This document is a regulatory clearance for a Class I medical device (non-powdered patient examination glove) which typically relies on established performance standards for physical properties rather than clinical performance studies described by the questions.

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The Disposable Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject devices have two color: blue and clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. This document is for a Class I medical device, which falls under general controls and typically does not require extensive clinical studies or complex performance criteria like those for AI-powered diagnostic tools. Therefore, the information needed to answer the prompt's specific questions regarding acceptance criteria, study methodologies for AI/software, ground truth establishment, expert adjudication, or MRMC studies for this type of device is not present in the document.

The document mainly focuses on demonstrating substantial equivalence to a predicate device (K163168) through:

• Identical Intended Use: Both devices are disposable gloves for preventing contamination between patient and examiner.
• Similar Technological Characteristics: Material (vinyl), design (ambidextrous, powder-free), and basic physical properties.
• Compliance with Recognized Standards: ASTM D5250 (physical dimensions, performance), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ISO 10993 (biocompatibility).

Based on the provided document, here's an attempt to address your questions, highlighting what information is available and what is not applicable or not provided for this type of device:

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

The document does not present acceptance criteria in a pass/fail table format, nor does it typically report specific "performance" metrics in the way an AI algorithm would (e.g., sensitivity, specificity). Instead, it shows comparative data with the predicate device against established standards.

Here's an extraction of relevant "performance" data and standards from the "Technological Characteristic Comparison Table" (Table3) and "Device Dimensions Comparison" (Table2), indicating compliance with ASTM standards which serve as de facto acceptance criteria for these physical properties:

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

The document refers to "non-clinical tests" such as those for physical properties, freedom from holes, powder content, and biocompatibility, which are conducted on samples of the manufactured gloves.

• Sample Size: The exact sample sizes for each specific test (e.g., number of gloves tested for tensile strength, number of gloves tested for holes, number of specimens for biocompatibility) are not explicitly stated in this summary document. These details would typically be found in the full test reports referenced by the standards (e.g., ASTM D5151 specifies sampling plans for AQL).
• Data Provenance: The tests were performed by the manufacturer (Shandong Shengshixincheng Medical Science & Technology Co., Ltd. is the submitter) and/or their designated testing labs. The country of origin for the data is implicitly China, where the manufacturer is located. The tests are prospective in the sense that they are performed on samples of the manufactured device to verify its properties.

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

This question is not applicable to this type of device. "Ground truth" established by experts (like radiologists for imaging) is relevant for diagnostic devices that interpret complex data or images. For examination gloves, the "ground truth" is defined by the physical and chemical properties measured against established engineering and biocompatibility standards (e.g., a glove either passes or fails a hole test, or its tensile strength meets the specified MPa). No human experts are needed to adjudicate these objective measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are specific to scenarios where human interpretation or consensus is required (e.g., in medical image reading trials). The tests for examination gloves involve objective measurements, not subjective human assessments 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

This question is not applicable. MRMC studies are used for evaluating the performance of diagnostic imaging devices, particularly those involving AI assistance, and comparing human reader performance with and without AI. This device is an examination glove, not a diagnostic imaging device or an AI product.

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

This question is not applicable. This device is a physical product (a glove), not an algorithm or software requiring standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective engineering standards, physical measurements, and chemical/biological test results. For example:

• Physical dimensions: Measured against specified ranges (e.g., length, width, thickness).
• Tensile Strength & Elongation: Measured in MPa and % elongation against minimum thresholds.
• Freedom from Holes: Determined by an objective test method (ASTM D5151) with an Acceptable Quality Limit (AQL).
• Powder Content: Measured against a maximum threshold (ASTM D6124).
• Biocompatibility: Determined by standardized in-vitro and in-vivo tests (ISO 10993-5, -10) for irritation, sensitization, and cytotoxicity.

These are not based on expert consensus, pathology, or outcomes data in the medical sense, but rather on compliance with established consensus standards for medical devices.

8. The sample size for the training set

This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

This question is not applicable, as there is no "training set" for this type of device.

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The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom from Holes or how many samples for Biocompatibility). It refers to compliance with standards like ASTM D5151, ASTM D6124, ISO 10993-10, and ISO 10993-5, which would have their own specified sampling plans.

The manufacturer is Shandong Zhushi Pharmaceutical Group Co., Ltd located in Shandong, China. The tests were conducted to demonstrate compliance with international standards, but specific data provenance within China is not detailed. The tests are non-clinical and would be considered prospective as they were performed to verify that the proposed device met design specifications before market approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a vinyl examination glove and the "ground truth" is established through adherence to recognized international and national standards for physical properties, chemical properties, and biocompatibility, not by expert consensus on interpretations of medical images or complex diagnostic assessments. The "ground truth" is objective measurement against specified criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments like medical image interpretation. For a physical medical device like gloves, the assessment is based on objective measurements and compliance with established standards, not expert 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 disposable vinyl examination glove, not an AI-powered diagnostic tool. MRMC studies are used for evaluating the effectiveness of AI in assisting human readers in diagnostic tasks.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the acceptance criteria is defined by recognized international and national standards (e.g., ASTM D5250 for physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder content, and ISO 10993-5/10 for biocompatibility). Test results are compared directly against the specifications outlined in these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for such a device.

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

Not applicable. As there is no training set for a physical device, this question is irrelevant.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E

This document is a 510(k) clearance letter from the FDA for disposable vinyl examination gloves. It does not contain information on acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot extract the requested information from the provided text.

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