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A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

The provided text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.

Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):

1. A table of acceptance criteria and the 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 hand or finger to prevent contamination between patient and examiner.

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided text describes the acceptance criteria and performance data for the "Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile". This is a medical device, and the data presented relates to its physical properties and biocompatibility, not an AI/ML-based device. Therefore, questions related to AI/ML specific aspects like expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable.

Here's the analysis based on the provided text, focusing on the relevant criteria for this type of medical device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Properties (Tensile Strength, Ultimate Elongation, Dimensions): The sample sizes are not explicitly stated for each specific test, but ASTM D412 and ASTM D3767 standards typically specify sample sizes for these types of tests.
• Watertight: The sample size used was 315 pieces (based on inspection level G1 for a batch size of 150,001 to 500,000 under AQL 1.5).
• Residual Powder: The sample size used was 5 pieces.
• Biocompatibility: The specific sample sizes for in vivo tests (like primary skin irritation, dermal sensitization, acute systemic toxicity) are not explicitly mentioned in terms of number of animals, but the standards (ISO 10993-10, ISO 10993-11) outline the appropriate sample sizes and methodologies for these studies.
• Data Provenance: The data is non-clinical test data conducted by Onetexx Sdn Bhd (Malaysia), indicated by the submitter's address. These are prospective tests performed on the device to demonstrate compliance with standards.

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

This question is not applicable. The device is a patient examination glove, and its performance is assessed through standardized physical and chemical tests (e.g., tensile strength, watertightness, biocompatibility), not through expert interpretation of medical images or other data requiring "ground truth" established by human experts.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, especially when human interpretation is involved. For physical and chemical testing of medical gloves, results are determined by adherence to established test procedures and measurement against quantitative criteria.

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 as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is established by objective measurements and standardized test procedures defined by ASTM and ISO standards (e.g., ASTM D412 for tensile properties, ASTM D5151 for watertightness, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this product's performance evaluation.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."

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

This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."

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