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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.

This request is about a medical device, but the provided text describes a "NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES". This type of product is a medical device, but it is not an AI/ML powered device, so acceptance criteria and study information mentioned in the request are not applicable.

However, since there are acceptance criteria and study data on device performance, I will provide the information accordingly.

Acceptance Criteria and Device Performance for Powder-Free Chocolate Scented Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

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

• Dimension, Tensile Strength, Ultimate Elongation: The data lists performance per size (X-Small, Small, Medium, Large) in "SGMP" columns. It's implied that these are measurements taken on samples of the gloves, but the specific sample size for each dimension or mechanical property test is not explicitly stated beyond "Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1125".
• Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested for both un-aged and aged conditions. This totals 1000 gloves tested (125 * 4 sizes * 2 conditions).
• Residual Powder Content, Presence of Cornstarch, Residual Protein Level: The data is reported as ranges or means for the product, implying sampling, but specific sample sizes are not explicitly provided.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it is retrospective or prospective. Given that it's a 510(k) submission from "SGMP Company Limited" with a contact person "Cheah Chor Hee," it is likely data collected by the manufacturer for the purpose of this submission (prospective data collection for regulatory approval).

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

Not applicable. This is a testing report for physical, chemical, and biological properties of a latex glove, not a performance study that requires expert judgment for ground truth establishment. The "ground truth" here is defined by objective measurement standards (e.g., ASTM standards, FDA requirements).

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is a report of objective measurements against specified standards, not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret outputs, often with and without AI assistance. This document describes the performance of a physical product (gloves), not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by adherence to recognized national and international standards and regulatory requirements. These include:

• ASTM D3578-00 Standard Specification for Latex Examination Gloves for Medical Application: This standard defines the acceptable ranges for dimensions and mechanical properties (tensile strength, ultimate elongation).
• FDA specified 1,000 ml water leak test: Used for the water-tightness assessment.
• Draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL: Used as the acceptance quality limit for the water leak test.
• Biocompatibility tests: Implied to be against recognized standards for medical devices, "passed the tests for examination gloves."
• ASTM D 6124-00: Standard for residual powder content.
• FDA Internal Requirement for Residual Powder Content: 2 mg/glove max.
• ASTM D 5712-99: Standard for residual protein level.
• FDA Allowable Level for Residual Protein Level: < 50 µg/g.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As described in point 8, there is no training set for this type of device.

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