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A powder-free 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.

Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

The provided text describes the performance testing and acceptance criteria for "Black Nitrile Examination Gloves, Powder Free, Non Sterile." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document also mentions other performance testing standards such as Water Leak Test (G-I, AQL 1.5), Visual Inspection (Critical AQL 0.65, Major AQL 2.5, Minor AQL 4.0), Residual Powder (N=5), and Moisture Content (N=8) in Section 5.0. However, the specific performance values for these tests are not detailed in Section 7.0 for the device.

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

The document mentions sample sizes for some tests:

• Residual Powder: N = 5
• Moisture Content: N = 8

For other tests like water leak, physical dimension, physical properties, and visual inspection, AQL (Acceptable Quality Limit) levels (e.g., G-I, AQL 1.5; S-2, AQL 4.0; S-2, AQL 2.5) are specified. These AQLs are part of a sampling plan that determines the sample size and acceptance/rejection criteria based on the lot size, but the exact number of units tested for each batch is not explicitly stated as a single "sample size" in the provided text.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. The submitter is PT MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA, implying the tests were conducted by or for them.

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

Not applicable. This is a medical device (gloves) and the "ground truth" for its performance is established by objective measurements against established engineering and safety standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20), not by expert human consensus on image interpretation or similar.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. Testing involves objective measurements, not human interpretation that requires 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-powered diagnostic device.

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 algorithm.

7. The type of ground truth used:

• Objective Measurements/Standards: The ground truth for performance claims is based on established international and national standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20) for physical properties, dimensions, freedom from pinholes, moisture content, and powder residue.
• Biological Testing: Biocompatibility (Primary Skin Irritation and Dermal Sensitization) uses standardized laboratory animal tests (rabbits) to determine "Pass" or "Fail" based on observed biological responses.

8. The Sample Size for the Training Set:

Not applicable. This product does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8.

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Senstouch High Risk Blue Latex Examination Gloves Powdeced, Non-Starile is a disposable device and mad of natural cubber latex for medical purpose that worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of natural rubber latex.

The provided text discusses an FDA 510(k) premarket notification for "Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile." It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, or study methodologies. It is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information based on the given input.

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A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.

The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The provided document outlines the acceptance criteria and performance of a device, but it is not a study in the typical sense of a clinical trial or comparative effectiveness research. Instead, it is a 510(k) Premarket Notification Summary for a medical device (Powdered Latex Examination Gloves, Non Sterile), which aims to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states:

• "The samples are from the final product." (for non-clinical performance data)
• "The sample items used during the Primary Skin Irritation Test and the Dermal Sensitization Test is from the final product." (for clinical performance data, which in this context refers to biocompatibility testing).

Sample Size: The exact sample size used for each specific test (e.g., how many gloves were tested for pinholes, how many rabbits for biocompatibility) is not specified in the provided summary.
Data Provenance: The device manufacturer is PT. MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA. This suggests the testing was either conducted in Indonesia or by a laboratory contracted by the Indonesian manufacturer. The data appears to be prospective in the sense that the tests were performed specifically for this 510(k) submission on samples of the final product.

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

Not applicable/Not described. This document is for a physical medical device (gloves), not an AI diagnostic or image analysis system. The "ground truth" here is objective physical and chemical measurements (e.g., dimensions, protein content, water leak) and results of standardized biological tests (e.g., skin irritation in rabbits), not expert interpretation of medical images or patient outcomes. Therefore, there's no mention of experts establishing ground truth in the way it would be for an AI study.

4. Adjudication Method for the Test Set

Not applicable. As mentioned above, this is about objective measurements against predefined standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. No MRMC study was performed or is relevant for this type of device (examination gloves). This type of study focuses on improving human reader performance with AI assistance, which is not the purpose of this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a passive physical barrier, not an algorithm or software. Therefore, the concept of standalone algorithm performance does not apply.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Objective Measurements: Directly measurable physical and chemical properties of the gloves (e.g., dimension, weight of powder, protein concentration).
• Standardized Test Results: Outcomes of well-established test methods described by ASTM standards and FDA regulations (e.g., water leak test for pinholes, specific tests for biocompatibility like Primary Skin Irritation in Rabbits and Dermal Sensitization).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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