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The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.

The provided text describes the 510(k) summary for "Sterile Latex Examination Gloves Powder Free". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing, rather than an AI-driven medical device requiring extensive clinical validation of diagnostic accuracy. As such, many of the requested elements for AI/ML device studies (like sample sizes for test sets, expert ground truth adjudication, MRMC studies, training set details) are not applicable to the information provided.

However, I can extract the acceptance criteria and performance results for the non-clinical tests conducted for these gloves:

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.

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.

Here's a breakdown of the requested information:

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

The document provides two tables that fulfill this request:

• A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
• A "Non-clinical Testing Summary" table on page 6.

Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.

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 does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.

The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.

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 to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.

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

Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple experts.

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 medical glove, not an AI-assisted diagnostic tool or system that involves human readers.

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

Not applicable. The device is a physical product (medical glove), not an algorithm.

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

The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
• ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
• ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.

The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.

8. The sample size for the training set

Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.

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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A patient examination 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 Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

The provided text is for a 510(k) Premarket Notification for a medical device, specifically a Powder Free Latex Patient Examination Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics, rather than extensive clinical studies as one might find for a novel diagnostic AI device.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and submission. The "study" here refers to the testing performed to meet specific ASTM standards and biocompatibility requirements.

Here's a breakdown of the information that is applicable and how it relates to the acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by existing ASTM standards and biocompatibility testing. The device's performance is reported as meeting these standards.

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

The document specifies that the device "meets all the current specification for ASTM D3578-05 (2010)" and refers to other ASTM and ISO standards for specific characteristics. Clinical data was "not needed for market cleared examination gloves."

• Sample Size for Test Set: The specific sample sizes for each test (e.g., pin-holes, dimensions, physical properties) are not detailed in this 510(k) summary. These would typically be specified within the individual ASTM and ISO standards referenced. For example, ASTM D5151-99 for freedom from pinholes often specifies a sample size based on the acceptable quality level (AQL).
• Data Provenance: The document does not explicitly state the country of origin for the data (e.g., where the tests were physically conducted) nor whether it was retrospective or prospective. Given the nature of performance testing against standards, it would be prospective testing of newly manufactured glove batches. The manufacturer is "Top Calibre Sdn Bhd" in Selangor, Malaysia, so the testing was likely conducted by or for them.

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

Not Applicable: This type of device does not involve a "ground truth" established by experts in a diagnostic or interpretive sense. The ground truth for performance characteristics is defined by the objective measurement criteria within the relevant ASTM and ISO standards (e.g., tensile strength, elongation, water leak rate, protein content measurement). Biocompatibility tests are performed by qualified laboratories and assessed against established toxicology criteria.

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

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, often in diagnostic imaging or clinical trials, to resolve discrepancies between readers. For physical and chemical tests of gloves, results are objectively measured against defined thresholds in the standards; there is no subjective interpretation requiring 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

Not Applicable: This device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessments of AI assistance are irrelevant.

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

Not Applicable: This device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is established by objective measurements against predefined criteria and thresholds set forth in the referenced ASTM and ISO standards.

• For Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Protein Content: The ground truth is the quantitative measurement of these properties (e.g., thickness, tensile strength, percentage of gloves passing water leak test, specific protein content in µg/dm²) compared to the specified limits in standards like ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, and ASTM D5712-10.
• For Biocompatibility: The ground truth is determined by the results of standardized biological tests (Dermal Sensitization and Primary Skin Irritation Tests as per ISO 10993-10:2010), which assess the device's potential to cause adverse biological reactions. The "ground truth" in this context is the observation of whether a reaction occurs and its severity, interpreted against established toxicity criteria, leading to a "pass" or "fail" determination (e.g., "Not a contact skin sensitizer," "Not a primary skin irritant").

8. The sample size for the training set

Not Applicable: This device does not use machine learning or AI, 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, this question is not relevant.

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

Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)

This document is a 510(k) premarket notification determination letter from the FDA for "Latex Examination Gloves Powder-Free (Black Color) and with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a previously cleared device. The "acceptance criteria" in this context would primarily pertain to compliance with FDA regulations, good manufacturing practices, and performance characteristics (like protein content, physical properties such as tensile strength and elongation, and freedom from holes) that demonstrate substantial equivalence to predicate devices, rather than a statistical study proving clinical performance of an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.

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Laglove TM Brand Latex Examination Gloves, Powder Free, Non - Sterile (Pink, Green and Violet) a patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Laglove TM Brand Latex Examination Gloves, Powder Free, Non - Sterile (Pink / Green / Violet)

The provided document is a 510(k) premarket notification letter from the FDA to Laglove (M) SDN. BHD. for their "Laglove Brand Colored Latex Examination Gloves, Powder Free". This document solely concerns the FDA's determination of substantial equivalence for this medical device and does not contain information about acceptance criteria or a study proving its performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device's market clearance is based on its similarity to existing, legally marketed devices, rather than on a new study proving its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the given document. The document describes regulatory approval based on substantial equivalence, not a performance study.

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High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.

HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE is a disposable device and made of natural rubber latex.

This document is about the FDA's 510(k) premarket notification for "High Risk Latex Examination Gloves, Powder Free, Non Sterile". It's a regulatory clearance document, not a study report for a novel medical device with AI components. Therefore, much of the information requested in the prompt (e.g., acceptance criteria for an algorithm, sample sizes for training/test sets, expert qualifications, MRMC studies) is not applicable or present in this type of document.

However, I can extract the relevant information about the "device" in question (gloves) and its regulatory classification.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the 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)

• Not applicable / Not provided. This document does not detail specific testing protocols or sample sizes for performance evaluation in the context of an AI/algorithm-driven device. For gloves, testing typically involves standards related to physical properties (e.g., tensile strength, barrier integrity, dimensions) and biocompatibility, but the specifics are not in this FDA letter. The device manufacturer (Pt. Mahakarya Inti Buana) is from Sumut, Indonesia.

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 / Not provided. This information is for evaluating AI or diagnostic device performance, not for gloves.

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

• Not applicable / Not provided. This pertains to expert review in AI studies.

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 / Not provided. This is relevant for diagnostic devices that involve human interpretation assisted by AI.

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

• Not applicable / Not provided. There is no algorithm described for this device.

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

• Not applicable / Not provided. The "ground truth" for gloves would relate to their physical and biological properties meeting established standards (e.g., ASTM standards for medical gloves) and regulatory requirements, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not applicable / Not provided. There is no AI model or "training set" for this device.

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

• Not applicable / Not provided. There is no AI model or "training set" for this device.

In summary, the provided document is a regulatory clearance for medical gloves, which are a physical product, not a software or AI-driven diagnostic device. Therefore, the specific questions regarding AI device performance evaluation, expert reviews, and data sets for algorithms are not relevant to this document.

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BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY™ Brand Latex Examination Gloves (Power Free, Black Color) Containing 50 ug or Less of water Extractable Protein Per Gram". It details the FDA's determination of substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, expert ground truth establishment, or any details about a study and its methodology as requested in your prompt. The document is an administrative approval letter, not a scientific study report.

Therefore, I cannot populate the table or answer the subsequent questions based on the information provided in the input.

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Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner

The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes the PT. MAHAKARYA INTI BUANA Polymer Examination Gloves, Powder Free, Non Sterile. The provided information focuses on non-clinical performance data and does not include details on clinical studies or AI-driven aspects.

1. Table of Acceptance Criteria and Reported Device Performance

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Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for Midas Touch Blue Latex Examination Gloves, confirming substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and marketing permissions. Therefore, I cannot fulfill your request based on the given input.

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