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The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).

The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.

For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.

Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)

For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
• Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.

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):

• Not applicable. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.

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

• Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test results.

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. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.

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

• Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.

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 engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.

8. The sample size for the training set:

• Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable due to the absence of a training set.

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Powder Free Nitrile Examination Gloves, Blue 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 Nitrile Examination Gloves, Black 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 Nitrile Examination Gloves, White 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 Powder Free Nitrile Examination Gloves, Violet Blue 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 Powder Free Latex 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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This document is a 510(k) premarket notification decision letter from the FDA for examination gloves. It does not contain information about an AI/ML powered medical device, a clinical study with acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document is for "Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves," which are Class I devices (non-powered patient examination gloves) and do not involve AI. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device.

To provide the requested information, the input text would need to describe a medical device that uses AI/ML and include details about its performance studies.

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Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Biodegradable Powder Free Latex Examination Gloves" and discusses regulatory compliance, not performance studies of a specific AI device. Therefore, I cannot generate the requested table and study details.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Glove

This appears to be an FDA 510(k) clearance letter for a Class I medical device, specifically "Powder Free Latex Examination Gloves." This type of clearance focuses on demonstrating substantial equivalence to a predicate device, primarily through established performance standards and manufacturing controls, rather than extensive clinical study data.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria, as typically seen for higher-risk devices or AI/software-as-a-medical-device (SaMD) products.

Here's why and what kind of information would typically be needed for the questions you've asked, if this were a different type of device:

• For a Class I device like examination gloves: The "acceptance criteria" primarily relate to national/international standards for glove performance (e.g., ASTM standards for barrier integrity, dimensions, tensile strength, protein content for latex gloves). The "study" proving this would involve laboratory testing against these standards, typically performed by the manufacturer and submitted to the FDA as part of their 510(k) application to demonstrate conformance. The provided document is the outcome of that review, not the detailed submission itself.

If this were a more complex device (e.g., an AI/SaMD product), the requested information would look like this:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Would typically define specific thresholds for performance metrics (e.g., sensitivity ≥ 90%, specificity ≥ 85%, AUC ≥ 0.90, average reading time reduction ≥ X seconds). These would often be based on clinical need, predicate device performance, or stakeholder input.
   • Reported Device Performance: Would present the actual values achieved by the device in predefined test sets for those metrics, along with confidence intervals.

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

   • Sample Size: A specific number of cases/patients (e.g., 500 cases).
   • Data Provenance: Details like "retrospective, multi-center data from 3 hospitals in the USA and 2 in Europe" or "prospectively collected data from a single academic institution in Japan."

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

   • Number of Experts: E.g., "3 experts."
   • Qualifications: "Board-certified radiologists, each with over 10 years of experience in chest imaging, including sub-specialization in oncology."

4. Adjudication method for the test set:

   • Method: E.g., "2+1 consensus (if two experts agreed, that was the ground truth; if they disagreed, a third expert resolved the discrepancy)" or "majority vote among 3 readers."

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Yes/No: Explicitly state if one was done.
   • Effect Size: "Readers improved their AUC by an average of 0.05 (from 0.85 to 0.90) with AI assistance, a statistically significant improvement (p

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A 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 LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS

This document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 ug/dm2 or Less." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on confirming the substantial equivalence of the device to legally marketed predicate devices and outlines the regulatory obligations of the manufacturer. There is no performance data, study design, or expert review mentioned within this text.

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Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml Water Leak Test.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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A 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.

Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).

This looks like a 510(k) premarket notification for non-sterile, powder-free latex examination gloves, which typically doesn't involve complex algorithms or AI. The acceptance criteria and "study" described here refer to conformance with established performance standards for medical gloves, rather than a clinical trial or AI model validation.

Therefore, many of the typical AI/ML study components (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

Here's a breakdown of the available information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a numerical count of individual gloves tested. The submission refers to meeting standards like "AQL 2.5" for pinholes, which implies a sampling plan defined by ASTM D3578. However, the specific number of gloves sampled for each test is not provided in this summary.
• Data Provenance: The testing was performed by "Siam Sempermed Laboratories in Thailand" for physical properties and "Consumer Product Testing" in Fairfield, New Jersey, USA for biocompatibility. This suggests a combination of in-house (Thailand) and third-party (USA) testing. The data is prospective in the sense that the manufacturer tested their actual product to demonstrate compliance.

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

• This is not applicable. The "ground truth" for glove performance is defined by the objective, quantifiable metrics within the referenced ASTM and ISO consensus standards (e.g., specific dimensions, tensile strength, protein limits, pinhole AQL). There are no "experts" establishing ground truth in the way a clinical study would for medical imaging.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, whereas these tests involve objective measurements against predefined thresholds in 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 device is a physical medical glove, not an AI or imaging device that uses "human readers" or "AI assistance."

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

• Not applicable. This is not an algorithmic or AI device. The performance tests are for the physical properties of the glove itself.

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

• The "ground truth" is established by consensus standards (ASTM D3578-05, ISO 10993-10/2002) which specify measurable physical, chemical, and biological properties that the gloves must meet for their intended use. These standards are developed through a consensus process involving experts in the field.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

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

Powder Free Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).

This document is a 510(k) premarket notification approval letter for "Powder Free Latex Examination Gloves, Tested For Use with Chemotherapy Drugs (Blue)". It is not a study that proves the device meets acceptance criteria in the sense of a clinical trial or AI algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device, which includes fulfilling certain performance standards for medical gloves.

Here's an analysis based on the provided document, addressing the requested points where information is available:

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

The document focuses on the chemotherapy drug permeation aspect of the gloves. While it doesn't explicitly state "acceptance criteria" in a separate column, the values presented are the "Average Breakthrough Detection Time in Minutes" for various chemotherapy drugs, which would be compared against a standard or established threshold for acceptable performance. The implicit acceptance criterion is that the breakthrough time should be as long as possible, ideally exceeding the duration of typical exposure.

Note: The document explicitly states: "Please note that Thiotepa has an extremely low permeation time of less than 30 minutes." This indicates that for Thiotepa, the performance is below a generally accepted threshold for robust protection and needs careful consideration.

2. Sample size 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. The document is an FDA approval letter, not a detailed study report. The results presented in the table are likely summarized from testing conducted by the manufacturer, but the specifics of the sample size (n for each test) and provenance are not included.

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 and not provided. This document pertains to the physical performance of a medical device (gloves) against chemical permeation, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the objective measurement of chemical breakthrough.

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

This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for chemical permeation testing of gloves.

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 document is for a medical glove, not an AI-assisted diagnostic tool.

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

This is not applicable. This document is for a medical glove, not an algorithm.

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

The "ground truth" for the chemotherapy drug permeation data would be the objective measurement of the breakthrough time of the specific chemotherapy drugs through the glove material. This is determined by standardized chemical testing protocols (e.g., ASTM D6978 for medical gloves). It does not involve expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the manufacturing process itself, aiming to meet established performance standards.

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

This is not applicable and not provided. As explained above, this is not an AI/machine learning device.

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A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).

The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.

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

This information is not provided in the document. The tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.

4. Adjudication method for the test set:

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test protocols.

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 MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.

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

No standalone algorithm performance study was done. This is a physical non-AI device.

7. The type of ground truth used:

The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:

• ASTM D3578-05 for Dimensions
• ASTM D 412-06ae1 for Physical Properties
• ASTM D 5151-06 for Freedom from pin-holes
• ASTM D 6124-06 for Powder Free Residue
• ASTM D 5712-05 for Soluble Protein Level
• ASTM F720-81 for Dermal Sensitization
• 16CFR Part 1500 for Primary Skin Irritation Test

These standards specify the methodology and acceptable limits for each characteristic.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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