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A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner

Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)

Here's an analysis of the provided 510(k) summary, breaking down acceptance criteria and the study information as requested.

The provided document describes Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less). It is a submission for a 510(k) premarket notification, which is a process to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data and does not typically involve extensive human clinical trials or AI performance evaluations as described for complex AI/ML-based medical devices.

Therefore, many of the requested points related to AI/ML studies (test sets, ground truth establishment, MRMC studies, standalone performance, training sets) are not applicable to this type of device and submission.

1. Table of Acceptance Criteria and Reported Device Performance

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This device is intended to be used as a single use disposable sterile examination glove.
This Examination Glove is a device made of natural rubber latex intended to be worn by medical personnel to prevent cross contamination between them and the patient.

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Examination Powder-free Latex Gloves, 80 LYY and meets all requirements of ASTM standard D-3578-95.

This submission describes the Kemwell Sterile Powder-Free Latex Examination Gloves. As a medical device, its performance criteria and the studies conducted are detailed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for each specific test (e.g., physical dimensions, water-fill test, skin irritation, sensitization). However, it mentions specific AQL (Acceptable Quality Level) values for inspection levels:

• Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5
• FDA 1000 ml. Water Fill Test: AQL 1.5, Inspection Level 1

These AQL values imply a statistically relevant sampling plan was used according to the specified ASTM and FDA standards for quality control testing.

The provenance of the data is retrospective, as the tests were performed on finished products to demonstrate compliance with established standards. The data originates from Kemwell International Ltd. in Bangalore, India, where the gloves are manufactured.

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

This type of submission for examination gloves does not typically involve human experts establishing a "ground truth" for the test set in the way a diagnostic AI device would. The "ground truth" for these performance tests is based on objective, quantifiable measurements against established engineering and safety standards (e.g., glove dimensions, force at break, waterproof integrity). Therefore, there is no mention of a number of experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are based on objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not relevant for this type of device (sterile powder-free latex examination gloves). Such studies are typically conducted for diagnostic or interpretive devices where human readers (e.g., radiologists, pathologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a physical barrier intended for protection.

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

No. This concept is not applicable to a physical product like examination gloves. "Standalone performance" refers to the accuracy of an AI algorithm in performing a task without human intervention, which is not relevant to the function of a glove.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective, quantifiable measurements against predefined performance and safety criteria specified in:

• ASTM-D-3578-95 (Standard Specification for Rubber Examination Gloves)
• FDA 1000 ml. Water Fill Test procedures
• Biocompatibility standards related to primary skin irritation and sensitization.

Essentially, the "ground truth" is compliance with these universally accepted standards for product quality and safety.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is guided by established engineering principles and quality control, not by training data for an algorithm.

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

Not applicable. As stated above, there is no training set for this device.

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