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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

It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only.

Characteristics:

• Ambidextrous with beaded cuff
• Blended synthetic latex (Chloroprene and Nitrile Latex)
• Blue or green Coloured ●
• Five sizes: X-Small, Small, Medium, Large and X-Large. ●

The provided document is a 510(k) Premarket Notification for Chloroprene Examination Gloves Powder Free (Blue, Green). This document focuses on demonstrating substantial equivalence to a predicate device, which involves comparing material, design, and performance characteristics for a medical device (examination gloves), not an AI/ML-driven device.

Therefore, the requested information regarding AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this document.

What the document does provide is a detailed comparison of the physical and biological characteristics of the proposed gloves against established ASTM standards and the predicate device.

Here's a summary of the acceptance criteria and reported performance for the Chloroprene Examination Gloves Powder Free (Blue, Green), as extracted from the provided text:

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)

• Sample Size: Not explicitly stated as a single "test set" sample size for a clinical study. The data presented are results of various laboratory and biocompatibility tests on the gloves. These tests typically involve a specific number of gloves or samples per test as per the ASTM and ISO standards referenced (e.g., AQL for water leak tests, specific batches for physical property tests). The exact number of gloves or samples for each test is not detailed in this summary, but the results confirm they "Meet" or "Pass" the specified standards.
• Data Provenance: The manufacturer is Careglove Global SDN BHD, located in Malaysia. The testing was conducted to comply with international standards (ASTM and ISO). The document does not specify whether the data is retrospective or prospective in the context of a clinical trial, as this is a premarket notification for a Class I general medical device based on engineering and biocompatibility testing.

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. This is a physical medical device (examination gloves) where "ground truth" is established through adherence to standardized laboratory test methods (ASTM, ISO) for physical properties and biocompatibility, not by expert interpretation of medical images or patient outcomes.

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

• Not Applicable. As per point 3, this is a physical device tested against objective standards, not an AI/ML system requiring human expert 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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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

• The "ground truth" for this device's performance is based on objective measurements defined by international standards (ASTM D6977-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-10, ISO 10993-5, ISO 10993-11) for physical properties (e.g., length, thickness, tensile strength, elongation, freedom from holes, powder residue) and biocompatibility (e.g., skin irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. This is not an AI/ML device; there is no "training set" or establishment of ground truth in that context.

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