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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Brand Name: Sensi-Pro)". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is an approval for the device based on its substantial equivalence to a predicate device already on the market, not a report of a new study designed to prove specific performance metrics.

Therefore, I cannot extract the requested information from the provided text. The document confirms the FDA's decision regarding the device's market eligibility but does not detail the technical studies, acceptance criteria, or performance data that would generally be part of a submission proving the device's technical capabilities.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)

The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige Color (Brand Name: Sensi-Pro)". This document is a regulatory approval and does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in the prompt.

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

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powdered Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)

The provided text is a 510(k) premarket notification approval letter for "Sensi-Pro, Disposable Powdered Vinyl Synthetic Examination Gloves." This document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt. The letter merely acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot extract the requested information from the provided text.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powder Free Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)

The provided text is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is strictly a regulatory approval letter.

Therefore, I cannot extract the requested information as it is not present in the given text.

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This glove is to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Glove, Patient Examination, Vinyl Powder Free

The provided document describes the acceptance criteria and performance data for "Shijiazhuang HongRay Plastic Products Co., Ltd. Vinyl Patient Examination Gloves (Powder Free)."

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided documents. The specifications are listed for four sizes (Small, Medium, Large, X-Large), implying testing across these different sizes. For quality assurance like "Pinhole Rate," it mentions "FDA GLOVE 1000 HL WATER LEAK TEST," suggesting testing a sample of 1000 gloves but not specifying if this is the sample size for the regulatory submission itself.
• Data Provenance: The document does not explicitly state "test set" data provenance for all tests. The manufacturing location is Shijiazhuang, China. Biocompatibility testing was conducted by "Consumer Products Testing Co., USA." It's retrospective testing of manufactured products to ensure compliance with standards.

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

This information is not applicable as the device is a medical glove, and the "ground truth" is established through physical and chemical testing against established standards (e.g., ASTM, JIS), not through expert interpretation of images or clinical data.

4. Adjudication method for the test set:

This information is not applicable for physical and biocompatibility testing of a medical glove. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving image interpretation or clinical expert review.

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:

This is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a patient examination glove, not a standalone algorithm.

7. The type of ground truth used:

The ground truth is established by industry standards and test methods. Specifically:

• ASTM Standard D5250-92
• JIS-S-2045 (various sections for dimensions and tensile properties)
• FDA GLOVE 1000 HL WATER LEAK TEST for pinholes
• Biocompatibility methods (Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler))

8. The sample size for the training set:

This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

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A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Glove, Patient Examination, Vinyl (Powdered)

The provided text describes the specifications and quality characteristics of Vinyl Patient Examination Gloves. It focuses on physical dimensions, material properties, and quality assurance for the gloves, referencing ASTM and JIS standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured according to your request:

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

Note: The table shows the "Reported Device Performance" as matching the "Acceptance Criterion" based on the conclusion statement: "Shinjiazhuang Hongray Plastic Products Co., Ltd. Vinyl Patient Examination Gloves meet ASTM Standards - meets pinhole requirements and labeling claims." This implies that the device did meet all specified criteria. The document provides the specifications for each size and characteristic, and the conclusion then confirms compliance.

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

The document does not specify the sample size used for the test set for any of the listed quality characteristics or the pinhole rate test. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). However, the company is based in China and Taiwan, and the testing laboratories (Consumer Products Testing Co., USA for biocompatibility) are mentioned, which gives an indication of where some testing might have occurred. The JIS standards are Japanese Industrial Standards, implying international applicability or adoption.

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 question is not applicable in the context of this device and study. The "ground truth" here is defined by objective, measurable physical and material properties (e.g., dimension measurements, tensile strength values, water leak test results for pinholes) according to established international standards (ASTM, JIS). Expert consensus is not typically used to establish these types of physical standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or subjective assessment is involved, often for clinical endpoints or image analysis. For objective physical measurements and material testing, the results are derived directly from the test procedures outlined in the standards, not through 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

This question is not applicable. The device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC comparative effectiveness studies, human readers, or AI assistance are irrelevant to its evaluation.

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

This question is not applicable. The device is not an algorithm. Its performance is measured directly through physical and material tests.

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

The "ground truth" in this context refers to the objective measurements and pass/fail criteria defined by recognized international standards such as ASTM Standard D5250 and various JIS-S-2045 sub-standards. For example, for tensile strength, the ground truth is "Min. 10.0 Mpa," and for pinholes, it's "Under 4% pinhole rate" as determined by the FDA glove water leak test.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for physical products like gloves undergoing these types of standardized tests. Machine learning models use training sets; physical products are tested against a defined set of specifications.

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

This question is not applicable, as there is no training set for this type of product evaluation. The "ground truth" (specifications) for the testing was established by the relevant national and international standards bodies (ASTM, JIS, FDA) that created and maintain these standards.

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