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

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" and FDA Water Leak Test.

The provided document describes the acceptance criteria and performance data for "Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves."

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

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

The document does not specify the exact sample sizes used for each test. However, it indicates compliance with ASTM D3578-01aE2 standards and FDA requirements. The data provenance is linked to SPI Gloves Sdn. Bhd. in Malaysia, and the tests were likely conducted by or for this manufacturer. The nature of the tests (physical properties, watertightness, etc.) suggests these are controlled laboratory tests rather than observational studies in a real-world setting. The summary was prepared on February 11, 2005.

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

Not applicable. The "ground truth" for the performance of examination gloves is established by objective, standardized tests and measurements as defined by ASTM D3578-01aE2 and FDA requirements, not by expert consensus or interpretation of subjective data. Physical properties, chemical content, and watertightness are quantifiable metrics.

4. Adjudication method for the test set

Not applicable. As described above, the performance is measured against objective standards, not 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 medical glove, not an AI-assisted diagnostic tool or an imaging device that involves human readers.

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

Not applicable. This device is a medical glove, not a software algorithm.

7. The type of ground truth used

The ground truth used for evaluating the device is based on objective, quantitative standards and tests specified by:

• ASTM D3578-01aE2 (Standard Specification for Rubber Examination Gloves)
• FDA 1000 ml watertight test
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)
• Protein content testing (below 50 microgram / gram)

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.

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

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 hands or finger to prevent contamination between patient and examiner.

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The provided medical device is the "Chlorinated Powder Free Latex Examination Gloves" manufactured by SPI Gloves Sdn. Bhd. It is a Class I device regulated under 21 CFR 880.6250 (Latex Patient Examination Glove) with product code LYY.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Chlorinated Powder Free Latex Examination Gloves are based on meeting ASTM D3578-01a2 (or D3578-01a52, as both appear in the document for the same standard) and FDA requirements, including water leak test and minimum powder residual content.

Note: The document specifies "ASTM D3578-01a2" in the table heading and "ASTM D3578-01a52" in the general description of the standard. Assuming these refer to the same standard. The asterisk () for physical properties refers to average results obtained from Attachment C, which is not provided in the input.*

Details of the Study Proving Acceptance Criteria

The provided documentation describes the types of tests conducted and their outcomes, but it does not provide a detailed study report that would include specific sample sizes, ground truth establishment, or expert involvement as typically understood for AI/diagnostic device studies.

Based on the available information, here's what can be inferred and what information is missing:

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

• Test Set Sample Size: Not explicitly stated for each test. For the "Watertight (1000 ml)" test, the Acceptance Quality Limit (AQL) of 2.5% is mentioned, which implies a sampling plan was used, but the specific sample size (e.g., number of gloves tested) is not given.
• Data Provenance: The tests were performed by the manufacturer, SPI Gloves Sdn. Bhd., in Malaysia. The type of study (e.g., retrospective or prospective) is not explicitly mentioned but these performance tests are typically conducted prospectively on manufactured batches.

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

• This is not applicable in the context of this device and these physical/chemical performance tests. "Ground truth" established by experts is typically for diagnostic devices assessing medical images or clinical data. For examination gloves, the "ground truth" is defined by the objective measurement of physical and chemical properties against established standards (ASTM, FDA).

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

• This is not applicable. Adjudication methods are used to resolve disagreements among human readers/experts in diagnostic studies. For these physical and chemical tests, the results are objective measurements from laboratory testing.

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, this was not done. This type of study is relevant for AI-powered diagnostic devices, not for examination gloves, which are physical barriers and do not involve human readers interpreting data enhanced by AI.

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

• Not applicable. This device is not an algorithm or AI system, so the concept of standalone performance does not apply.

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

• The "ground truth" for the performance claims of these gloves is defined by established regulatory and international standards (ASTM D3578-01a2/a52 and FDA requirements). For example, a glove is considered "watertight" if it passes the 1000 ml test with an AQL of 2.5%. "Tensile strength" is determined by mechanical testing against a minimum threshold. "Powder content" is determined by chemical analysis against a maximum threshold.

8. The sample size for the training set:

• Not applicable. This device is not an AI or machine learning model, so there is no "training set." The tests are performed on samples from manufacturing batches.

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

• Not applicable, as there is no training set for an AI/ML model.

In summary:

The provided document demonstrates that the "Chlorinated Powder Free Latex Examination Gloves" meet the specified performance criteria based on objective physical and chemical testing against recognized standards (ASTM D3578-01a2/a52) and FDA requirements. The information required for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication, MRMC studies, or training data details) is not relevant for this type of medical device and is therefore not present in the submission.

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

Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for Powdered Latex Examination Gloves manufactured by SPI GLOVES SDN. BHD. This document is a 510(k) premarket notification for a medical device.

Please note that this document is for a physical product (gloves) and not an AI/ML powered device, so several of the requested categories (like MRMC study, effect size, human-in-the-loop, etc.) are not applicable and will be marked as "N/A".

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

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

The document does not explicitly state a specific sample size for the tests. The performance data is reported as meeting the standards, implying that adequate samples were tested for each criterion according to ASTM D3578-01aE2 and FDA requirements. The data provenance is from Malaysia (SPI GLOVES SDN. BHD. is located in Ipoh, Perak, Malaysia). The data appears to be prospective as it represents the performance testing conducted by the manufacturer for their product prior to submission.

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

N/A. This is a physical product (gloves) undergoing standardized physical and chemical tests, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" is defined by the objective measurement standards of ASTM D3578-01aE2 and FDA requirements.

4. Adjudication method for the test set

N/A. The testing involves objective measurements against established technical standards (ASTM D3578-01aE2) and FDA requirements. There is no human adjudication process described beyond the performance of the specified tests.

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

N/A. This is not an AI/ML powered device.

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

N/A. This is not an AI/ML powered device.

7. The type of ground truth used

The ground truth is established by objective technical standards and regulatory requirements:

• ASTM D3578-01aE2 Standard: This is a widely recognized standard specification for rubber examination gloves. It defines the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and watertightness.
• FDA Water Leak Test: A specific FDA requirement for glove watertightness.
• FDA Minimum Powder Residual Content: A specific FDA requirement regarding the amount of powder on the gloves.
• Biocompatibility Tests: Standardized tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the biological response to the glove material.

8. The sample size for the training set

N/A. This is a manufactured product, not an AI/ML model that requires a training set.

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

N/A. This is a manufactured product, not an AI/ML model that requires a training set or its associated ground truth establishment.

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

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.

Here's a breakdown of the requested information:

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

Ask a specific question about this device

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

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The provided submission (K050529) is for a medical device that does not involve artificial intelligence (AI). It is a 510(k) premarket notification for "Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim." As such, the concept of a "device" in this context refers to the examination gloves themselves, and the acceptance criteria and supporting study are related to the physical and performance characteristics of these gloves, not an AI algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of medical device submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document refers to "Performance data of gloves based on ASTM D3578-01 a22 FDA 1000 ml watertight test." and "The average result obtained from Attachment C." However, the exact sample size used for the performance tests (e.g., watertightness, physical properties, thickness) is not explicitly stated in the provided text. ASTM D3578-01aE2 specifies an AQL (Acceptable Quality Level) of 2.5%, implying a statistical sampling plan (e.g., ISO 2859-1 or similar), but the specific number of units tested is not provided.
• Data Provenance: The manufacturing entity is "SPI GLOVES SDN. BHD." located in Malaysia. The tests conducted would presumably be performed on gloves produced in Malaysia.

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

• Not applicable. The ground truth for glove performance is established through standardized laboratory testing against objective criteria (e.g., measurements for length and thickness, tensile testing for physical properties, chemical analysis for powder and protein content, and standardized water leak tests). There is no "expert" (like a radiologist) establishing a subjective truth.

4. Adjudication method for the test set:

• Not applicable. Performance data is derived from objective measurements and standardized tests, not subjective interpretations 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 is not an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• Objective measurement and standardized test results against established engineering and chemical specifications (ASTM D3578-01aE2 for physical properties, FDA requirements for watertightness, powder content, and protein content).
• Biocompatibility testing (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) against established biological safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set in the AI sense. The manufacturing process of the gloves could be considered "trained" through quality control and process optimization over time, but not in the context of a "training set" for an algorithm.

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

• Not applicable. This is not an AI device.

Ask a specific question about this device

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

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

This looks like a 510(k) premarket notification for examination gloves, which are low-risk devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the device meets established ASTM standards and FDA requirements for such products, rather than clinical efficacy trials common for higher-risk medical devices.

Here's the breakdown of the information requested, based on the provided text:

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

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