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A powder-free patient examination gloves 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.

Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.

This document describes the regulatory submission for the "RS Care Latex Examination Gloves Powder Free." It's important to note that this is a 510(k) summary for a medical device (gloves), not an AI/ML powered device. Therefore, many of the requested categories in your prompt, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "sample size for the training set," and "adjudication method," are not applicable.

Here's the breakdown based on the provided text, focusing on the relevant acceptance criteria and study information for this type of device:

Acceptance Criteria and Device Performance Study for RS Care Latex Examination Gloves Powder Free

1. Table of Acceptance Criteria and Reported Device Performance

*Note: The "Conclusion" statement mentions the device "shall perform according to the glove performance standards," implying that studies were conducted to confirm this, as indicated by the "Meets" and "Passes" in the performance column for each characteristic.

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

The document does not specify the exact sample sizes used for each test (e.g., for dimension testing, pinhole testing, etc.). The testing aligns with established ASTM standards (ASTM D 3578-05), which typically outline sampling plans, but the specific numbers are not provided in this 510(k) summary.

Data Provenance: The device manufacturer, Riverstone Resources Sdn. Bhd., is located in Selangor, Malaysia. It is implied that the testing was conducted either internally by the manufacturer or by a contracted laboratory adhering to the specified standards. The data is retrospective in the sense that the tests were performed on finished product batches to demonstrate compliance prior to market approval.

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

Not applicable. This is not a study requiring expert interpretation of complex data (like medical images). The "ground truth" here is determined by objective measurements and standardized laboratory tests (e.g., measuring glove dimensions, counting pinholes, chemical analysis for protein content, and biological assays for biocompatibility) according to the specified ASTM and CPSC standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on predefined measurement criteria and laboratory procedures, not subjective interpretation 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

Not applicable. This is a physical medical device (gloves), not an AI/ML powered diagnostic or assistive technology.

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

Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth is based on objective measurements and chemical/biological assay results obtained through standardized laboratory testing procedures as defined by:

• ASTM D 3578-05 (for Dimension, Physical Properties, Freedom from pinholes, Powder-Free, and Protein Content)
• Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for Primary Skin Irritation Test)
• ASTM-F 720-81 (Reapproved 2007) (for Dermal Sensitization Assay)

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is controlled to ensure consistent product characteristics that meet the defined standards.

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

Not applicable. There is no "training set" in the context of this device's regulatory submission.

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