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Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Latex Examination Gloves Powder Free With Lined.

The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.

The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
• The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.

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

The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.

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

This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."

4. Adjudication Method for the Test Set

This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective assessments 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

This question is not applicable. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.

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

This question is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
• Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
• Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").

8. The Sample Size for the Training Set

This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.

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

This question is not applicable, as there is no "training set" for this type of device. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.

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Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shiva Medicare Limited Latex Examination Gloves (Powder free):

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The Shiva Medicare Limited Latex Examination Gloves (Powder free) meet or exceed all the specified acceptance criteria from ASTM D3578-95 and FDA pinhole requirements, as reported in the Conclusion of Performance Test Data.

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

• Sample Size: Not explicitly stated. The document refers to "Performance test data of the powder free examination glove manufactured by Shiva Medicare Limited" but does not detail the number of units tested for each characteristic. It mentions AQL (Acceptance Quality Limit) levels (S4, S2) which implies a sampling plan, but the specific sample sizes used per test are not provided.
• Data Provenance: The data is generated by Shiva Medicare Limited, located in India (Madras Export Processing Zone, Chennai). The data is prospective as it's presented as the performance of the manufactured device tested against established standards.

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

• Not Applicable. This study is a performance test of a medical device against established industry standards (ASTM D3578-95) and regulatory requirements (FDA pinhole requirement). Ground truth here is defined by these pre-existing technical specifications, not by expert consensus on individual "cases" or "images."
• There were no "experts" establishing a case-by-case ground truth in the traditional sense of a diagnostic study. The "ground truth" is the published standard.

4. Adjudication method for the test set

• Not Applicable. As explained above, this is a product performance test against predefined technical standards. There is no adjudication of findings between multiple reviewers as would be seen in clinical image interpretation studies. The measurements are objective physical properties.

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 is a performance study for a physical medical device (gloves), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

• No. This is a performance study for a physical medical device (gloves), not an algorithm. This concept does not apply.

7. The type of ground truth used

• The ground truth used is a combination of:
  • Expert Consensus/Standard: The established international standard ASTM D3578-95 for Latex Examination Gloves. ASTM standards are developed through a consensus process involving experts in the field.
  • Regulatory Requirement: "FDA Pinhole Requirement."

8. The sample size for the training set

• Not Applicable. This is a performance study for a physical medical device (gloves), not a machine learning model. Therefore, there is no "training set" in this context. The product is manufactured and then tested to ensure it meets specifications.

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

• Not Applicable. As there is no training set for a machine learning model, this question does not apply.

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