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The Patient 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 proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.

The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).

Here's an analysis of the provided information, focusing on the requested aspects.

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

Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.

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)

The document extensively lists the accepted criteria for various tests, but it does not explicitly state the sample sizes used for each specific test in the provided tables. For example, for "Detection of Holes", it simply states "0 Glove leakage" without indicating how many gloves were tested to achieve this. Similarly, for biocompatibility tests, it reports results (e.g., "No sensitization response") but not the number of animals or cells used.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text. The submission is from 3A Glove Sdn. Bhd. (Malaysia), with a designated correspondent in Shanghai, China, but this doesn't clarify where the tests themselves were conducted or the origin of the samples.

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 the document describes non-clinical performance testing for medical devices (gloves), not a diagnostic device or AI system that requires expert interpretation for establishing ground truth. The tests are based on objective physical, chemical, and biological measures against established standards.

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

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.

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 the document is for a medical device (patient examination gloves) and not an AI-assisted diagnostic device. No comparative effectiveness study with human readers or AI assistance was conducted or discussed.

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

This information is not applicable as the device is a patient examination glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to report.

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

The "ground truth" for the non-clinical performance tests is based on established objective measurements and standardized test methods as defined by recognized international and national standards (ISO, ASTM). For example:

• Biocompatibility: Adherence to biological response criteria in animal models (ISO 10993 series).
• Physical Properties: Measurement of dimensions, tensile strength, and elongation against specifications in ASTM standards (e.g., D6319, D412).
• Hole Detection: Compliance with acceptable quality levels (AQL) as per statistical sampling plans (ASTM D5151, ISO 2859).
• Powder Content: Direct measurement against a defined limit (ASTM D6124).

The acceptance criteria themselves serve as the "ground truth" that the device must meet.

8. The sample size for the training set

This information is not applicable. The device is a physical product (nitrile gloves), not an artificial intelligence or machine learning system that requires a "training set."

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

This information is not applicable for the same reason as point 8. No training set or associated ground truth establishment is relevant to the conformity testing of patient examination gloves.

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The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.

This is a 510(k) premarket notification for nitrile examination gloves, not an AI/ML medical device. Therefore, the request for acceptance criteria and study details related to AI/ML performance metrics (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable.

The document assesses the substantial equivalence of the proposed device (Nitrile Examination Gloves) to a predicate device (Powder Free Nitrile Patient Examination Gloves, Blue Color) based on non-clinical testing and comparison of technological characteristics.

Here’s a breakdown of the relevant information provided:

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

The document provides a comparison of the proposed device with a predicate device, referencing ASTM standards for acceptance criteria. The performance of the proposed device is stated as meeting these requirements.

Note: The table above extracts information primarily from the "Comparison of technological characteristics with the predicate devices" section and the "Non-Clinical Testing" section.

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 applicable as this is a medical glove submission and not an AI/ML device. The "test set" in this context refers to the samples of gloves tested according to the specified ASTM and ISO standards, not a data set for an algorithm. The document doesn't detail the sample sizes for each physical or biocompatibility test, but it indicates adherence to the standards. The manufacturing country of origin is China (Guang Dong Kingfa SCI. & TECH.CO., LTD.).

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. "Ground truth" in the AI/ML sense is not relevant here. The "ground truth" for glove performance is established by the defined ASTM and ISO standards, and testing is performed by laboratories that adhere to these standards.

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

This is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations of medical images or data. Standardized laboratory testing methods do not involve such adjudication processes.

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 is not applicable. This is not an AI-assisted device.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the gloves is based on established industry standards (ASTM D6319-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D573-04(2019), ASTM D412-16, ISO 10993-10: 2010, ISO 10993-11:2017). These standards define the acceptable physical properties and biocompatibility characteristics for medical examination gloves.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Clove and Latex Powder Free Examination Gloves with Colloidal Oatheriz United Protectant with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove - Lemon Green is a non -- sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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This document is a FDA 510(k) premarket notification letter for a medical device: "Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove."

The document does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI-powered medical device. It pertains to a physical medical device (examination gloves) and its regulatory clearance process, not a software or AI device.

Therefore, I cannot extract the information to fill your table or answer your questions. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts, their qualifications, or ground truth establishment methods for test sets.
4. Adjudication methods.
5. Details of MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for training sets.
9. Methods for establishing ground truth for training data.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves (Blue), non-sterile.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the study proving the device meets the acceptance criteria, the provided document is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI/imaging device. Therefore, many of the requested points below (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this type of submission for examination gloves.

However, based on the information provided, we can infer the following about the testing and evidence:

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

• Sample Size: Not explicitly stated. For physical property testing of gloves, sample sizes are typically defined by the specific ASTM standards (e.g., a certain number of gloves per batch for dimension, tensile strength, and freedom from holes testing).
• Data Provenance: Not explicitly stated, but based on the nature of manufacturing and testing for medical devices, it would be retrospective data collected during the production and quality control processes of the manufacturer (THAI HUA HOLDING COMPANY LIMITED). The country of origin of the data would likely be Thailand, where the manufacturer is located, or potentially the location of the testing laboratories.

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

• Not Applicable. For physical and biocompatibility testing of gloves, "experts" in the sense of clinician reviewers establishing ground truth for disease detection are not relevant. The "ground truth" is objective measurement against specified standards. Testing would be performed by lab technicians or engineers trained in the relevant ASTM and ISO standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As the "ground truth" relies on objective measurements against standards, an adjudication method for different human interpretations is not needed. Test results either meet the numerical criteria or they don't.

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 an examination glove, not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. See point 5.

7. The type of ground truth used:

• Objective Measurements/Standards: The ground truth for this device's performance is established by the specified ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, and Consumer Product Safety Commission regulations. For example:
  • Dimensions and Physical Properties: Direct measurements of glove size, tensile strength, elongation, etc., compared against the numerical ranges defined in ASTM D 6319-00a(2005).
  • Freedom from Holes: Water leak testing as per ASTM D 5151-06, yielding a quantified Acceptable Quality Level (AQL).
  • Powder Free Residual: Measurement of residual powder, compared against the limit in ASTM 6124-06.
  • Biocompatibility: Results from standardized animal (rabbit, guinea pig) tests for irritation and sensitization, evaluated against established toxicology protocols.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set." The testing methods are based on established engineering and materials science principles.

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

• Not Applicable. See point 8.

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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Latex Examination Gloves. non-sterile.

The provided text describes a 510(k) premarket notification for "Powdered Latex Examination Gloves" by THAI HUA HOLDING CO. LTD. It outlines the device's characteristics, intended use, and conformance to standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "DEVICE PERFORMANCE" column indicates that the gloves meet or pass the specified criteria, demonstrating compliance with the referenced ASTM, CPSC, and ISO standards.

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

The document does not specify the sample size used for the test set (e.g., how many gloves were tested for dimensions, holes, etc.).

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be conducted by the manufacturer to demonstrate compliance with international 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 and therefore not provided in the document. The "ground truth" for this type of device (examination gloves) is established by adherence to predefined objective physical and chemical standards (e.g., ASTM, ISO), not by expert opinion or interpretation in a medical imaging or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical image reading) where disagreements between experts need to be resolved. For objective physical and chemical tests, the results are quantifiable and do not require 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 relevant for diagnostic devices where human readers interpret results, and the impact of an AI algorithm on their performance is being evaluated. For medical gloves, the performance is assessed against objective technical standards, not through human reader interpretation.

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

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, verifiable physical and chemical standards as defined by:

• ASTM D 3578-05: Standard Specification for Rubber Examination Gloves (for dimensions, physical properties, freedom from holes).
• ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D 5712-99: Standard Test Method for the Measurement of Latex Allergens in Natural Rubber and Latex Products.
• CPSC Title 16, Chapter II, Part 1500:41: For Primary Skin Irritation in Rabbits.
• ISO 10993-10: 2002(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (specifically for Guinea Pig Sensitizations).

These standards provide the definitive criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The manufacturing process of gloves does not involve machine learning training sets.

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

This information is not applicable as there is no training set for this type of physical device.

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A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.

Powder-Free Vinyl Examination Glove

The provided documentation describes the acceptance criteria and a study demonstrating that the Cartagloves S.A. Powder-Free Vinyl Examination Glove meets these criteria, supporting its substantial equivalence claim.

1. Acceptance Criteria and Reported Device Performance

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

The documentation does not explicitly state the specific "sample size" for each test (e.g., number of gloves tested for dimensions, physical properties, or pinholes). However, it implies that the testing was conducted according to the sampling plans outlined within ASTM D5250, ASTM D5151, and ASTM D6124, which typically include specific AQL (Acceptable Quality Level) and inspection levels for quality control.

The data provenance is not explicitly stated in terms of country of origin but is from the applicant, Cartagloves S.A., located in Cartagena, Colombia. The testing appears to be internal to the manufacturer or conducted by a designated lab on their behalf. The data is presented as retrospective performance data collected to support the 510(k) submission.

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 device. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards (ASTM and ISO), not subjective expert interpretation of images or clinical data. There is no concept of "ground truth" established by experts in the context of these types of engineering and material performance tests.

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

This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation (e.g., medical image reading) requires consensus among multiple evaluators. For the performance testing of examination gloves, the measurements are objective (e.g., tensile strength, dimensions, pinhole count) and determined by standardized test procedures, 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

This question is not applicable to this device. An MRMC study with AI assistance is relevant for diagnostic devices that analyze medical images or data. The Cartagloves S.A. device is an examination glove, which is a physical barrier device, and does not involve human readers or AI in its intended use or performance evaluation.

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" typically refers to the performance of an AI algorithm or an automated diagnostic system operating without human interaction. This is not relevant for a physical medical device like an examination glove.

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

The "ground truth" for the performance of the examination glove is defined by adherence to published and accepted industry standards:

• ASTM D 5250-06 ("Standard Specification for Poly(vinyl chloride) Gloves for Medical Application")
• ASTM D 5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993 (Biological evaluation of medical devices)

The device's performance against these quantifiable criteria (e.g., specific dimensions, tensile strength values, AQL levels for pinholes) constitutes the "ground truth" for its safety and effectiveness relative to the specified standards.

8. The sample size for the training set

This question is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The Cartagloves S.A. device is an examination glove, and its manufacturing and testing do not involve machine learning or AI.

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

This question is not applicable to this device, as there is no "training set" in the context of examination glove manufacturing and testing.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

This document is a 510(k) premarket notification for patient examination gloves. It approves the device as substantially equivalent to a predicate device. The information provided does not contain details about specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, which is implied by the detailed questions.

Instead, this document pertains to a physical medical device (examination gloves) and its approval process by the FDA based on substantial equivalence. Therefore, I cannot directly answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as they are not applicable to the content of this document.

The document indicates:

• Device Name: Omni Flex Nitrile Examination Glove, Powder Free, Turquoise
• Intended Use: "A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient."
• Regulatory Class: I
• Product Code: LZA
• FDA Action: Substantial Equivalence determination based on comparison to pre-amendment devices, subject to general controls (annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration).

To answer your specific questions in the context of an AI/ML powered medical device, I would need a different type of document that describes a performance study for such a device.

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Ask a specific question about this device

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Ask a specific question about this device