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This device is intended to be used as a single use disposable sterile surgical glove.
This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO and meets all requirements of ASTM standard D-3577-91.

The provided documents describe the acceptance criteria and a study to demonstrate the substantial equivalence of Kemwell International Ltd.'s "Coloured Powder-free Latex Surgical Gloves" (later specified as "Green Powder-Free Latex Surgical Gloves") to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensional Testing: Inspection Level S-2, AQL 2.5. The exact number of gloves sampled is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level per ASTM standards.
• Pinhole (Water Fill Test): AQL 1.5, Inspection Level 1. The exact number of gloves sampled is not explicitly stated but is determined by the AQL and inspection level per FDA standards.
• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests (e.g., number of test subjects or animals) is not specified in the provided text.
• Data Provenance: The device manufacturer, Kemwell International Ltd., is based in Bangalore, India. The document does not explicitly state the country of origin for the test data, but it is implied to be associated with tests conducted by or for Kemwell. These seem to be prospective tests performed specifically for this 510(k) submission.

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

This type of information is not applicable to this submission. The tests performed are objective, laboratory-based evaluations against established industry standards (ASTM D 3577-91) and regulatory requirements (FDA Water Fill Test, biocompatibility). Expert consensus for "ground truth" as typically seen in AI or diagnostic device studies (e.g., radiologists interpreting images) is not a component of glove testing.

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective measurements against defined acceptance limits, there is no need for an adjudication method by human 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 (surgical gloves). This is a study demonstrating compliance with product standards rather than a comparative effectiveness study involving human readers or interpretation of results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This submission is for a physical medical device (surgical gloves), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the objective performance specifications defined by:

• ASTM D 3577-91 standards for physical and dimensional properties.
• FDA 1000 ml. Water Fill Test requirements for pinhole integrity.
• Biocompatibility testing standards for primary skin irritation and sensitization.

These standards and requirements serve as the benchmarks against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (surgical gloves). There is no "training set" in the context of machine learning, as this device does not involve an algorithm that learns from data.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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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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This device is intended to be used as a single use disposable sterile surgical glove.

Powder-free Latex Surgical Gloves which meets the requirements of ASTM D 3577-91.

This document describes the Glovel Gx Powder-free Latex Surgical Gloves and provides information for its 510(k) submission.

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

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "samplings of AQL 1.5, Inspection Level I" for the FDA 1000 ml Water Fill Test and "Inspection Level S-2, AQL 2.5" for Physical and Dimensions Testing. However, specific numerical sample sizes for these tests are not provided.

The data provenance is implied to be from the manufacturer's own testing as part of the 510(k) submission. The submitting company is from India (Kemwell International Ltd., Bangalore, India). The studies appear to be prospective as they are conducted to demonstrate conformance and equivalence.

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

This information is not applicable and not provided in the document. The device is a surgical glove, and its performance is assessed against established ASTM standards and FDA tests (e.g., water fill, biocompatibility), not through expert interpretation of data like medical imaging.

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

This information is not applicable and not provided. The assessment involves objective measurements against predefined standards and thresholds, not expert adjudication of subjective findings.

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 information is not applicable and not provided. The device is a surgical glove, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is a surgical glove, not an algorithm.

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

The "ground truth" for this device is based on established industry standards (ASTM D-3577-91), regulatory requirements (FDA 1000 ml Water Fill Test, 21 CFR references), and objective laboratory test results (e.g., physical properties, biocompatibility, sterility assurance, skin irritation/sensitization).

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which this device is not. The manufacturing process is designed to meet standards, rather than "trained" on data.

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

This information is not applicable and not provided for the same reasons as point 8.

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