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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.

Class I nitrile patient examination glove 80LZA, powder free and meeting all the requirements of ASTM Class Finance partierd Specification for nitrile Examination Gloves for Medical Application, except for the elongation at break parameter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the POWDER FREE GREEN COLOR SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES:

1. Table of Acceptance Criteria and Reported Device Performance:

The device (SGMP's) is compared against the ASTM D6319-00a standard (except for elongation at break, for which SGMP's performance is listed directly).

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

• Sample Size:
  • Dimension, Tensile Strength, Ultimate Elongation, Residual Powder, Cornstarch: Not explicitly stated for each test, but the results are reported for "SGMP's" and indicate measurements across different sizes (X-Small, Small, Medium, Large) and under "Before Aging" and "After Aging" conditions. The specific number of gloves tested for each individual measurement (e.g., how many gloves were measured for X-Small tensile strength before aging) is not provided.
  • 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 (4 sizes * 125 gloves/size * 2 aging conditions).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing conducted by "SGMP's" (the manufacturer) for submission to the FDA.

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

This is a physical product (examination gloves), not an AI/imaging device that requires expert interpretation for ground truth. Therefore, the concepts of "experts" and their "qualifications" as typically applied to medical image analysis or diagnostic AI studies are not relevant here. The ground truth for these tests is established by physical measurement against established laboratory standards (e.g., ASTM D6319-00a, ASTM D3578-00, ASTM D6124-00, biocompatibility testing protocols).

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert opinions or interpretations. The tests are based on objective physical and chemical properties measured against defined standards.

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-assisted device, nor does it involve human "readers" or case interpretation.

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

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used:

The ground truth used is based on established industry standards and laboratory testing protocols. Specifically:

• ASTM-D6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application for dimensions, tensile strength, and ultimate elongation.
• FDA specified 1,000 ml water leak test, evaluated against ASTM D3578-00 requirements for examination gloves (2.5% AQL).
• Biocompatibility tests (dermal irritation and skin sensitizer testing).
• ASTM D 6124-00 for Residual Powder Content.
• Tests for the Presence of Cornstarch.

8. The sample size for the training set:

Not applicable. There is no training set as this is a physical product, not a machine learning model.

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

Not applicable. There is no training set for this device.

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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.

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.

This document describes the acceptance criteria and performance of the "POWDER-FREE, 'BARRIER-PRO™, SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN" manufactured by Shield Gloves, as submitted for 510(k) clearance (K011613).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The device explicitly states that it meets/exceeds ASTM-D3578 Standard Specifications for Latex Examination Gloves, except for the elongation at break parameter. However, the provided tables show that the "Ultimate Elongation" for the Shield Gloves exceeds the ASTM-D3578-00 requirement for both before and after aging. This might be a misunderstanding of the "elongation at break parameter" or an older ASTM standard being referenced in the summary text. Based on the provided table, the performance for Ultimate Elongation is better than the ASTM standard.

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

• Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested specifically for the water leak test (4 sizes * 125 gloves/size * 2 aging conditions).
• Tensile Strength & Ultimate Elongation: The data is reported for each size (X-Small, Small, Medium, Large) for both before and after aging. The specific number of samples tested for these mechanical properties is not explicitly stated, but it is reported for "Lot# 1128".
• Residual Powder Content: The range (0.7-1.5mg/glove) and mean (1.05 mg/glove) suggest multiple samples were tested, but the total sample size is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Shield Gloves Manufacturing (M) Sdn Bhd is the applicant and is located in Malaysia (implied by "Sdn. Bhd." and context), it is highly likely the testing was conducted by or for the manufacturer, presumably in Malaysia, as part of their product development and regulatory submission. The testing would be considered prospective for the purpose of this 510(k) submission.

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

Not applicable. This device is a medical glove, and its performance is evaluated against engineering and material standards (e.g., ASTM D3578) and regulatory requirements (e.g., FDA water leak test, biocompatibility, powder content). Ground truth is established by these objective standards and tests, not by expert interpretation of clinical images or subjective assessments typically requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., in clinical trials or image interpretation) where multiple experts might disagree on an outcome. For objective physical and chemical tests of a medical glove, the results are typically quantitative measurements or pass/fail criteria based on defined standards, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical glove and does not involve AI or human "readers" in its intended use or evaluation.

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

Not applicable. This device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most of the performance criteria is based on established industry standards and regulatory requirements:

• ASTM-D3578-00/99: "Standard Specification for Latex Examination Gloves for Medical Application" (for Dimension, Tensile Strength, Ultimate Elongation).
• FDA specified water leak test: A specific methodology for determining watertight integrity.
• Biocompatibility standards: Tests for dermal irritation and skin sensitization.
• ASTM D 6124-00: For Residual Powder Content.
• FDA claim criterion: For a powder-free glove (presence of cornstarch).

These standards define the objective and measurable criteria for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of physical goods involves quality control and process validation, which might use statistical sampling (e.g., during production runs) but is distinct from an AI training set.

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

Not applicable, as there is no training set for this physical device.

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