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The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.

Chlorinated Powder Free Latex Examination Gloves (Yellow)

This document is a 510(k) clearance letter from the FDA for Chlorinated Powder Free Latex Examination Gloves (Yellow). It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.

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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 Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Chlorinated Powder Free Latex Examination Gloves

This document is an FDA 510(k) clearance letter for "Chlorinated Powder Free Latex Examination Gloves." This type of document is generally about regulatory approval of a medical device and does not typically contain detailed acceptance criteria or study results in the manner requested. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, subject to general controls provisions.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided:

1. A table of acceptance criteria and the reported device performance: This document does not contain specific acceptance criteria or detailed performance data for the "Chlorinated Powder Free Latex Examination Gloves." The FDA clearance is based on substantial equivalence, implying the device meets the standards of its predicate without necessarily requiring a report of novel performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.

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 or available for this type of device clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or available for this type of device clearance.

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-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this type of device (examination glove). The "ground truth" for a medical glove typically relates to its material properties, barrier function, and sterility, which are assessed through standardized tests rather than clinical outcomes or expert consensus on interpretations.

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.

In summary, this document is a regulatory approval letter based on substantial equivalence and does not contain the detailed technical or clinical study data requested.

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