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A patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.

This is not a medical device that utilizes AI/ML. The provided text describes a 510(k) submission for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.

The acceptance criteria and study detailed in the document pertain to the physical properties, biocompatibility, and regulatory compliance of these medical gloves, not to the performance of an AI/ML powered device.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for training/test sets, expert qualifications, or MRMC studies, as these concepts are not applicable to the device described.

However, I can extract the relevant information for the glove device based on the provided text:

Acceptance Criteria and Reported Device Performance for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves

Regarding the other requested points, they are not applicable to this medical glove device:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "samplings of AOL 2.5, Inspection Level I" and "Inspection Level S-2, AOL 2.5" for physical testing and water fill tests, which refers to Acceptable Quality Levels (AQL) for manufacturing quality control, not a sample size for an AI/ML test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove involves standardized physical and chemical tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device is based on standardized testing protocols and ASTM standard specifications (ASTM-D-6319-05) for physical properties, barrier integrity (water leak test), and biocompatibility.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML 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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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 (White)

The provided information describes a K100075 premarket notification for "Powder-free Vinyl Patient Examination Gloves, Colored (White)". This is a medical device subject to general controls and a substantial equivalence determination, not an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable because these types of studies are not typically conducted for this class of device.

However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For general purpose examination gloves, extensive human-reader test sets are not typically required. The tests focus on material properties and regulatory compliance.

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 and not provided in the document. Ground truth for glove testing pertains to meeting specific physical, chemical, and biological standards, not expert consensus on medical images or clinical outcomes.

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

This is not applicable and not provided. Performance is determined by meeting objective standards, not by expert adjudication of human readers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive devices, not for examination gloves.

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

This is not applicable. The device is a physical product (gloves), not an algorithm.

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

The ground truth used for the device performance evaluation is based on established industry standards and regulatory requirements:

• ASTM standard D 5250-06 (for Dimensions and Physical Properties)
• 21 CFR 800.20 (for Freedom from pinholes - Waterleak test AQL)
• ASTM standard D 6124-06 (for Powder Residual)
• ISO 10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/ML model that requires 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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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, Clear(non-colored) 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, Clear(non-colored)".

It's important to note that this document is a 510(k) summary for a Class I medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies with human subjects. Therefore, many of the typical AI/ML study questions won't be directly applicable as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of an 'n' count for the tests. However, the tests are performed according to recognized standards (ASTM, ISO, CFR) which inherently define sampling plans. For instance, 21 CFR 800.20 for freedom from pinholes typically involves inspection of a specific number of gloves per lot (often based on AQL – Acceptable Quality Limit).
• Data Provenance: The data is generated from testing the manufactured gloves as per the specified standards. This is prospective in the sense that the manufacturer tests their product. The country of origin of the device manufacturer is Tangshan, China.

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

• Number of Experts: Not applicable in the context of this device and study type. The "ground truth" for the physical and biocompatibility properties are defined by established international and national standards (ASTM, ISO, 21 CFR).
• Qualifications of Experts: The assessment relies on the expertise of personnel qualified to conduct tests according to these standards (e.g., lab technicians, quality control engineers) and interpret the results against the defined acceptance limits.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The results are objective measurements against predefined thresholds within the standards. There is no subjective interpretation requiring adjudication among experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret results, often with and without AI assistance. This document pertains to a physical examination glove, for which such a study is not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI-driven device. The "performance" refers to the physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on established industry standards and regulatory requirements. These standards define measurable parameters (e.g., tensile strength, elongation, freedom from pinholes, powder residue limits, biocompatibility test results) and their acceptance limits.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The manufacturing process of the gloves would have internal quality control procedures and potentially process validation steps, but these are distinct from "training a model."

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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