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Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner

The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., for dimension, pinholes, etc.). It only indicates that the device "Meets" the specified standards.

• Data Provenance: The manufacturing company is PT Mandiri Inti Buana, located in Tanjung Morawa, SUMUT - INDONESIA. It is implied that the testing was conducted by or for this manufacturer, although the specific testing location is not mentioned. The document does not specify whether the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert consensus on diagnostic images or clinical outcomes. The "ground truth" is established by the defined ASTM and FDA test methods and their acceptance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance is determined by direct measurement against quantitative and qualitative standards using defined test methods, not by expert adjudication of subjective assessments.

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 device is a medical glove, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is a physical product (medical glove), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements:

• ASTM standard D 3578-01 ae²: This is a standard specification for rubber examination gloves.
• FDA 21 CFR 800.20 (for Freedom from Pinholes) and FDA 1000 ml Water Leak Test: These are regulatory requirements for pinhole detection in medical gloves.
• D6124 - 01: Standard test method for residual powder on medical gloves.
• D 5712 - 99: Standard test method for analysis of protein in natural rubber latex products.
• Primary Skin Irritation in Rabbits and Dermal Sensitization tests: These are standard biological evaluation tests to assess biocompatibility.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

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

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

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