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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 the patient and the examiner.

Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00
Material: Latex
Cuff: Beaded
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

The provided document describes the acceptance criteria and the study results for the UniGlove Lano-E Powder-Free Latex Examination Gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

"Meets" or "In compliance" implies the device performed within the specified acceptance criteria. Specific numerical results for each criterion are not provided in the summary, only the conclusion that they meet the standards.

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

The document does not explicitly state the specific sample sizes used for testing each criterion. However, it indicates that the quality assurance is in compliance with ASTM D3578-00, which would dictate the sampling plans and statistical methods for determining compliance.

• Data Provenance: Not explicitly stated, but the submission is from N.S. Uni-Gloves Sdn. Bhd. (Malaysia), suggesting the testing likely occurred there or was conducted on products manufactured there. It is a premarket notification for a medical device; thus, the data would be prospective for the purposes of demonstrating regulatory compliance.

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 to this type of device and study. The "ground truth" for examination gloves is established by objective physical and chemical testing against defined standards (ASTM D 3578-00 and FDA 1000 ml water test). It does not involve expert interpretation or subjective assessment of images or medical conditions.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical imaging) where discordant expert opinions need resolution. For physical and chemical properties of gloves, objective measurements are taken, eliminating the need for adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This device is a patient examination glove, which does not involve human interpretation in its primary function for performance evaluation in this context.

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

This concept is not applicable to the UniGlove Lano-E Powder-Free Latex Examination Gloves. "Standalone" performance refers to an algorithm's ability to perform a task without human intervention, typically in AI/ML applications. A glove's performance is determined by its physical and chemical properties, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises objective measurements against established national and international standards. Specifically:

• ASTM Standard D 3578 - 00: For physical properties (dimensions, tensile strength, elongation, pinhole AQL).
• FDA 1000 ml water test: For water tightness/pinhole integrity.
• EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989: Other international standards for quality assurance.
• Specific material properties: Powder residue limit, protein content claim.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (examination glove) whose performance is evaluated against material and manufacturing standards. There is no "training set" in the context of machine learning or AI models for this device.

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

This information is not applicable as there is no training set for this device.

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