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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

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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 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

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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

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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.

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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.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow).

It's important to note that this document is for a Class I medical device (patient examination gloves). For devices of this classification, the regulatory requirements are generally less stringent compared to higher-risk devices, and often the "studies" primarily involve adherence to recognized standards rather than complex clinical trials or AI performance evaluations.

Here is the requested information:

1. Table of acceptance criteria and the reported device performance

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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.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to your requests:

Acceptance Criteria and Device Performance Study

The device reviewed is "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)" from Hebei Handform Plastic Products Co.,Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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

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.

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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