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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Shijiazhuang Star Plastic Powdered Vinyl Patient Examination Gloves:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (Dimension, Physical Properties, Freedom from pinholes, Powder Amount). For Biocompatibility, it mentions "rabbits" and "guinea pig" as test subjects, implying a small animal study; specific numbers are not given. The studies are non-clinical, meaning they were conducted in a lab setting, not with human subjects. Data provenance is not specified beyond being part of the manufacturer's evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these device performance tests (e.g., dimensions, physical properties, pinholes) is established by adherence to recognized ASTM standards and FDA regulations, not by expert consensus on individual cases. For biocompatibility, the ground truth is determined by standard toxicological testing protocols, not expert consensus in the human sense.

3. Adjudication method for the test set: Not applicable for these types of objective device performance tests that rely on adherence to established standards and measurement protocols.

4. 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 patient examination glove, not an AI-powered diagnostic or assistive medical imaging device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • For Dimension, Physical Properties, and Powder Amount: Adherence to ASTM standard D 5250-06.
   • For Freedom from pinholes: Adherence to 21 CFR 800.20.
   • For Biocompatibility: Results from standard animal primary skin irritation and dermal sensitization tests (likely following ISO10993-10 guidelines, as referenced).

7. The sample size for the training set: Not applicable. This device is a physical product, not a machine learning model that requires a training set. The performance is based on manufacturing processes and material science, validated against established standards.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for a physical device. The "ground truth" for manufacturing is the adherence to design specifications and quality control procedures that ensure the product meets the cited standards.

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Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the premarket notification (510(k)) summary for Shijiazhuang Star Plastic Co., LTD's Powder Free Vinyl Patient Examination Gloves. It details the device's characteristics, intended use, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical testing data. It does not specify a separate "test set" in the context of machine learning or AI. Instead, the "device performance" relies on material testing and biocompatibility studies.

• Sample Size: Not explicitly stated as a numerical count of gloves for each test. The performance is reported as meeting the specified standards, implying a sufficient sample size was tested to confidently demonstrate compliance.
• Data Provenance: The tests are described as non-clinical testing data, likely conducted by the manufacturer or contracted labs. The country of origin of the data is not specified, but the manufacturer is from China. The studies are prospective in the sense that they are performed on the device to determine compliance.

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

This information is not applicable to this submission. The "ground truth" for this medical device submission is established by the objective criteria set forth in recognized standards (ASTM, CFR, ISO) for physical properties and biocompatibility.

4. Adjudication Method for the Test Set:

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI algorithm evaluations where human expert consensus is required for ground truth, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC comparative effectiveness study was done. This type of study is used for diagnostic devices, particularly those involving image interpretation by human readers. This submission is for patient examination gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a physical medical device (gloves), not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is based on objective measurements and observations as defined by:

• Standard Specifications: ASTM standard D 5250-06 for dimension, physical properties, and powder residual.
• Regulatory Requirements: 21 CFR 800.20 for freedom from pinholes.
• Biocompatibility Standards: ISO10993-10 for primary skin irritation and dermal sensitization.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

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

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