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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 5250-06e1.

The device under consideration is "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It references ASTM standards and FDA regulations, implying that the sample sizes would be in accordance with the requirements of those standards.

The provenance of the data is not specified beyond the compliance with international and US standards. The submitter's address is in China, suggesting the testing might have been conducted in China, but this is not explicitly stated. The nature of the studies (e.g., whether they were retrospective or prospective) is not detailed, but given the nature of product testing, they would generally be prospective studies conducted specifically for this submission.

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

This information is not provided because expert consensus or human interpretation is not the primary ground truth for the performance of examination gloves. The ground truth for these types of devices is based on objective, quantifiable measurements against established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers or experts, which is not relevant for the objective performance testing of examination gloves.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation of images or data is involved. For examination gloves, the performance evaluation relies on objective physical and chemical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. "Standalone performance" or "algorithm only" studies are relevant to AI/ML software devices. This device is a physical medical device (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's performance evaluation is based on established industry standards and regulatory requirements. Specifically:

• Engineering specifications: ASTM standard D 5250-06 e1 for dimensions and physical properties.
• Regulatory limits: 21 CFR 800.20 for freedom from pinholes (waterleak test AQL).
• Chemical analysis: ASTM D6124-06 for powder residue.
• Biocompatibility guidelines: AAMI / ANSI / ISO 10993-10 for irritation and sensitization.

These standards define the objective criteria that the gloves must meet to be considered safe and effective.

8. The Sample Size for the Training Set:

Not applicable. This device is an examination glove, not an AI/ML algorithm that requires a training set. The "training" for a manufactured product is implicitly part of the manufacturing process and quality control, ensuring consistency with specifications.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The ground truth for the manufacturing process is established by the design specifications and quality control procedures that ensure the gloves meet the performance criteria outlined in the standards, but this is not a "training set" in the AI sense.

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