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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided document describes the acceptance criteria and study for the HEBEI LEADER PLASTIC CO., LTD's "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)." This is a medical device, and the evaluation focuses on its conformance to established standards for 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 explicitly state the sample sizes used for each specific test (e.g., ASTM D5151, D6124, biocompatibility). However, it implies that the device "meets" these standards, which typically involve specific sampling plans and test methods outlined within the respective standard.

• Data Provenance: The manufacturing company is HEBEI LEADER PLASTIC CO., LTD, located in Shijiazhuang, China. The testing likely occurred in China, although the specific laboratories are not identified.
• Retrospective or Prospective: The testing appears to be prospective as it was conducted to demonstrate substantial equivalence for the premarket notification (510(k)) of a new device.

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

This type of information is not applicable (N/A) for this device. The "ground truth" for medical gloves is established by adherence to recognized consensus standards (like ASTM and ISO) for physical properties and biocompatibility. It does not involve subjective human interpretation or diagnostic decision-making that would require expert consensus on a test set.

4. Adjudication Method for the Test Set

This is not applicable (N/A) for this device. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers evaluate data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth. For medical gloves, performance is measured against objective physical and chemical 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (often AI-powered) where human performance can be augmented or improved by AI assistance. This device is a patient examination glove, not an AI diagnostic tool.

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

No, a standalone (algorithm only) performance assessment was not done. This concept is applicable to AI/ML algorithms. The device being reviewed is a physical medical glove.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on recognized consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10 for biocompatibility). These standards define objective pass/fail criteria for the physical and chemical properties of the gloves.

8. The Sample Size for the Training Set

This is not applicable (N/A). Training sets are used for machine learning algorithms. The evaluation of this medical glove relies on physical and chemical testing against established standards, not on training an AI model.

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

This is not applicable (N/A) for the same reason as above. There is no AI training set involved.

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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the exact sample sizes used for each test. However, it indicates that the tests were performed according to established standards like ASTM and ISO, which would inherently involve specific sample sizes.

The data provenance is not explicitly stated in terms of country of origin, but the submission is from RONGYAO PLASTIC PRODUCE CO., LTD in China. The tests are non-clinical, implying they are laboratory-based and likely conducted prospectively to evaluate the device's conformance to standards.

3. Number of Experts and Their Qualifications

This information is not applicable. The device is a "Powder free Vinyl Patient Examination Gloves," and its performance is evaluated against technical standards and biocompatibility tests, not clinical assessment by experts.

4. Adjudication Method

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth from ambiguous or complex data, such as medical images. For the technical performance of examination gloves, the outcome is determined by objective measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is designed to evaluate the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance. This type of study is not relevant for a patient examination glove, which is a physical device and not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. This study type is for AI algorithms. The device in question is a physical glove, and its "standalone" performance is assessed by meeting the listed technical and biological compatibility criteria.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM standards (D 5250-06e1, D6124-01) for physical characteristics.
• 21 CFR 800.20 for freedom from pinholes.
• ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

8. Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning algorithms. This device is a manufactured product and does not involve AI algorithms that require training data.

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

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

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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)". This is a medical device and not an AI/ML powered device, therefore most of the requested information (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance) is not applicable or not found in the document.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable or not found:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to meeting standards (ASTM, FDA regulations for pinholes, ISO for biocompatibility tests), which typically involve specific sampling plans outlined in those standards, but the specific sample sizes used for this submission are not detailed.
• Data Provenance: Not explicitly stated. The testing was conducted to meet international and US standards. The submitter is from China, so the testing was likely conducted in or for the company in China, but this is an inference rather than explicitly stated. The studies are non-clinical, essentially laboratory-based testing of material properties, rather than human subject data.

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 physical product (gloves) and its performance is assessed against physical and chemical standards, not through expert interpretation of data.

4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, particularly in medical imaging or diagnostics, where multiple experts might disagree. This device's performance is objectively measured 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
Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.

7. The type of ground truth used
The "ground truth" for this device's performance is defined by the objective metrics and thresholds established in the referenced standards:

• ASTM standard D 5250-06 for dimension, physical properties, and powder residual.
• 21 CFR 800.20 for freedom from pinholes (waterleak test on pinhole AQL).
• ASTM D6124-01 for powder residual.
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization methods).

8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.

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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and related study information for the device described in the provided 510(k) summary:

This device is a Powder free Vinyl Patient Examination Glove. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which primarily involves meeting recognized standards for physical properties, safety, and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized ASTM standards and FDA regulations for patient examination gloves. The reported device performance states that the device "Meets" these standards.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for testing each characteristic (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It simply states that the device "Meets" the standards.
• Data Provenance: The tests are implied to be conducted by the manufacturer, TANGSHAN KANGJIA GLOVE CO., LTD., which is based in China. The data could be considered internal manufacturer data from China. Whether it's retrospective or prospective is not explicitly stated, but typically these types of tests are conducted prospectively as part of product development and quality control.

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

This type of device (patient examination glove) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" here is defined by objective, measurable criteria specified in ASTM standards and FDA regulations (e.g., a pinhole is present or not, tensile strength is within a range). Therefore, no "experts" in the clinical sense are used to establish ground truth for this device's performance. The "experts" might be the technicians and engineers who perform the standardized tests.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are not applicable to the testing of patient examination gloves. The tests involve objective measurements and pass/fail criteria based on established standards, rather than subjective interpretations that would require multiple reviewers and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. For a patient examination glove, there is no "reading" involved, and therefore, such a study is not applicable.

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

Yes, in a conceptual sense, a "standalone" assessment was done. The device's performance characteristics (dimension, physical properties, freedom from pinholes, powder residual, biocompatibility) were evaluated directly against the established standards without human intervention in the interpretation of the results beyond performing the standardized test. There is no algorithm, but its physical qualities were tested independently.

7. The Type of Ground Truth Used

The ground truth used is primarily objective, measurable criteria defined by recognized standards (ASTM) and regulatory requirements (21 CFR). For example:

• Dimensions: Measured against specified ranges in ASTM D 5250-06.
• Physical Properties: Measured against specified tensile strength, elongation, and other properties in ASTM D 5250-06.
• Freedom from Pinhole: Assessed via water leak test against AQL (Acceptable Quality Level) in 21 CFR 800.20.
• Powder Residual: Measured gravimetrically against the threshold of <2mg/glove.
• Biocompatibility: Assessed through standardized animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) to determine if irritation or sensitization occurs, according to ISO10993-10 guidelines.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product, and its manufacturing and quality control do not typically involve data-driven model training.

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

As there is no training set for this device in the AI/ML sense, the question of how its ground truth was established is not applicable.

Ask a specific question about this device

Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the acceptance criteria and study information for the K102570 submission, formatted as requested:

Acceptance Criteria and Device Performance Study for K102570

The device in question is "Powder free Vinyl Patient Examination Gloves, Colored (Yellow)." The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and FDA regulations for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided document, the studies conducted are non-clinical, focusing on laboratory testing rather than clinical trials involving human subjects.

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, pinholes, etc.). However, it indicates adherence to established standards (ASTM, ISO, 21 CFR), which typically define appropriate sampling methodologies for such tests.

The data provenance is from Tangshan Kangjie Glove Co., Ltd. (China), and the tests would be considered prospective as they were conducted to demonstrate compliance of the manufactured gloves.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable. The "ground truth" for glove performance is established by technical standards and regulations (ASTM D5250-06, 21 CFR 800.20, ASTM D6124-01, ISO10993-10), not by expert consensus on individual cases. Lab technicians and engineers with expertise in these standards would conduct the tests.

4. Adjudication Method for the Test Set

This section is not applicable. The evaluations are based on objective measurements and pass/fail criteria defined by the cited standards, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, sometimes with AI assistance. For patient examination gloves, the performance evaluation is based on material properties and regulatory compliance, not reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. The device is a physical product (gloves), not an algorithm or AI system. Its performance is inherent in its material and manufacturing, not in an independent computational process.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on technical standards and regulatory requirements. Specifically:

• ASTM D5250-06: Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard dictates requirements for dimensions, physical properties, and powder residue.
• 21 CFR 800.20: Regulations regarding general requirements for performance standards, specifically related to the waterleak test for freedom from pinholes.
• ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of evaluating physical properties of patient examination gloves. The manufacturing process is controlled to ensure consistent product quality, but there isn't a machine learning model being trained.

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

This section is not applicable, as there is no training set for this device.

Ask a specific question about this device

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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow):

Acceptance Criteria and Device Performance Study

The information provided describes the non-clinical testing performed to establish substantial equivalence for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow).

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 exact sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility studies).

• Test Set Sample Size: Not explicitly stated. The standards (ASTM D5250-06, 21 CFR 800.20, D6124-06, ISO 10993-10) define statistical sampling plans, but the specific number of units tested in this submission is not provided in the summary.
• Data Provenance: The studies are non-clinical, likely performed by the manufacturer or a contract research organization (CRO) in China, given the submitter's address. The data is retrospective in the sense that the testing was performed, and the results are being submitted for regulatory review.

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

This type of information is generally not applicable to the non-clinical testing of patient examination gloves. The "ground truth" is established by adherence to standardized testing protocols and measurement methodologies defined by the cited ASTM and CFR standards, not by expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly when interpreting subjective outputs like medical images. For the non-clinical tests described for these gloves, the results are objective measurements (e.g., pass/fail for pinholes, numerical values for powder residual, observed biological reactions) and do not involve an adjudication process. The determination of "meets" or "passes" is based on comparing the measured outcome to the predefined threshold in the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are relevant for devices involving interpretation by multiple human readers (e.g., radiologists, pathologists) and assessing the impact of a device (like AI) on their performance. This device is a disposable medical glove, and its performance is evaluated through standardized physical and biological testing, not by human reader interpretation.

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

This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical medical product (a glove), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by the objective performance criteria specified in the referenced industry standards and regulations:

• Physical Properties: Defined by ASTM standard D 5250-06 (e.g., minimum tensile strength, elongation, dimensions).
• Freedom from Pinholes: Defined by 21 CFR 800.20 (Water Leak Test) with specific Acceptable Quality Limits (AQLs).
• Powder Residual: Defined by ASTM standard D 5250-06 and D6124-06 (maximum powder weight per glove).
• Biocompatibility: Defined by ISO 10993-10 (tests for primary skin irritation and dermal sensitization) with specific criteria for "passes" (e.g., minimal or no observed reaction).

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve machine learning or AI algorithms requiring a training set.

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

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

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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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the safety and effectiveness information for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) manufactured by Tangshan Jiteng Plastic Products Co., Ltd.

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 exact sample sizes used for each specific test (e.g., dimension, physical properties, pinholes, powder residual, biocompatibility tests). However, it implies that the device was tested to meet the requirements of the specified ASTM and CFR standards, which typically involve specific sampling plans.

• Data Provenance: The testing was conducted by or for Tangshan Jiteng Plastic Products Co., Ltd., based in China. The data is reported as part of a premarket notification for a medical device, indicating it's retrospective testing performed to demonstrate compliance with established standards.

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

This information is not applicable as the device is a patient examination glove, and the objective safety and performance characteristics are determined by standardized physical and chemical tests rather than expert interpretation of medical images or data. The "ground truth" for these tests is the quantitative measurement against the established limits in the respective standards (ASTM D 5250-06, D6124-06, 21 CFR 800.20, ISO10993-10).

4. Adjudication Method for the Test Set

This is not applicable as the testing involves objective measurements against established standards, not judgmental evaluations 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 typically performed for diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, for which such a study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical medical glove and does not involve any algorithms or artificial intelligence.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on objective measurement against established regulatory and consensus standards. This includes:

• ASTM standard D 5250-06: For dimensions and physical properties (e.g., tensile strength, elongation).
• 21 CFR 800.20: For freedom from pinholes (water leak test).
• ASTM standard D 6124-06: For powder residual.
• ISO10993-10: For biocompatibility (Primary Skin Irritation and Dermal Sensitization).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve any machine learning algorithms that would require a training set.

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

This is not applicable, as there is no training set for this device.

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