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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

The 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.

COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.

The provided text describes the acceptance criteria and performance of the COMFIT Powder Free Nitrile Examination Glove, Sterile, against ASTM D 3578-99 standard and FDA 1000 ml watertight test.

Here’s a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

1. Single Sampling Plan, G-I, AQL 2.5
2. Multiple Sampling Plan, G-II, AQL 4.0 |
   | 2. Length (mm) | | |
   | XS | min 220 | - |
   | S | min 220 | 248 |
   | M | min 230 | 250 |
   | L | min 230 | 260 |
   | XL | - | - |
   | 3. Palm Width (mm) | | |
   | XS | $70 \pm 10$ | - |
   | S | $80 \pm 10$ | 84 |
   | M | $95 \pm 10$ | 95 |
   | L | $111 \pm 10$ | 104 |
   | XL | - | - |
   | 4. Single Wall Thickness (mm) | | |
   | Finger | min 0.08 | 0.21 |
   | Palm | min 0.08 | 0.14 |
   | 5. Physical Properties | | |
   | Before Aging : | | |
   | Tensile Strength (MPa) | min 14.0 | 23.88 |
   | Ultimate Elongation (%) | min 700 | 669 |
   | After Aging : | | |
   | Tensile Strength (MPa) | min 14.0 | 20.48 |
   | Ultimate Elongation (%) | min 500 | 668 |
   | 6. Residual Powder | Less than 4mg/glove | Less than 2mg/glove |

Note: The device did not meet the ultimate elongation before aging criteria (669% vs min 700%). The document later states, "The performance test data of device as shown above indicate that these nitrile gloves meet requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test." However, the conclusion states, "Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength. Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength." This implies the tensile strength was the critical parameter for equivalence despite the elongation discrepancy.

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

• Sample Size: The document does not explicitly state the specific number of gloves tested for each individual parameter (Length, Palm Width, Thickness, Tensile Strength, Elongation, Residual Powder). For the watertight test, it mentions "Single Sampling Plan, G-I, AQL 2.5" and "Multiple Sampling Plan, G-II, AQL 4.0," which are statistical sampling plans, but the exact sample size chosen based on these plans is not specified.
• Data Provenance: The tests were conducted by WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The data is retrospective in the sense that the tests were performed on finished products to demonstrate compliance with existing standards.

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

• This type of device (examination gloves) does not typically involve "experts" in the sense of medical professionals establishing a ground truth for a test set. The ground truth is objective, measurable physical properties defined by the ASTM D 3578-99 standard and the FDA 1000 ml watertight test. The "experts" would be the personnel performing the standardized laboratory tests according to established protocols, likely with relevant certifications or training in materials science or quality control. The document does not specify the number or qualifications of these individuals.

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

• Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in medical imaging or clinical trials where expert consensus is needed to resolve discrepancies. For objective physical testing of gloves against a standard, such adjudication is not applicable. The results are typically quantitative measurements and pass/fail criteria.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study relates to diagnostic accuracy and reader performance in interpreting medical data, often with AI assistance. It is not relevant to the physical performance testing of medical gloves.

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

• No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which is not applicable to a physical medical device like an examination glove. The performance described is of the glove itself.

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

• The ground truth used is primarily standardized test criteria and specifications defined by:
  • ASTM D 3578-99 Standard Specification for Rubber Examination Gloves
  • FDA 1000 ml watertight test
• These standards specify the acceptable ranges for physical properties (length, width, thickness, tensile strength, elongation, residual powder) and performance criteria (watertightness).

8. The sample size for the training set:

• This concept is relevant for machine learning models. For a physical medical device like an examination glove, there is no "training set" in the computational sense. The manufacturing process is designed for consistency, and quality control samples are taken from production lots.

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

• As there is no "training set" in this context, the question is not applicable. The "ground truth" for the device's design and manufacturing is adherence to the established ASTM and FDA standards.

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