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Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.

The provided text is for a 510(k) premarket notification for Nitrile Examination Gloves, a Class I medical device. This type of device is a physical product, not an AI/ML algorithm or software. Therefore, the "acceptance criteria and the study that proves the device meets the acceptance criteria" requested in the prompt refers to physical and biological performance testing for the gloves, not to a study about the performance of an AI model.

Here's the breakdown of the information based on the provided text, adapted for a physical device:

Acceptance Criteria and Device Performance for Nitrile Examination Gloves

The study to prove the device meets acceptance criteria involved non-clinical tests based on recognized standards for medical gloves.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for dimensions, holes, etc.) or the provenance of the materials/specimens (e.g., country of origin, retrospective or prospective). It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the "ground truth" for a physical device like medical gloves is established through direct physical, chemical, and biological testing according to predefined standards and objective measurements, not by expert consensus on interpretations. The tests are performed by trained personnel in laboratories.

4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against pass/fail criteria from recognized standards, not 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 is a physical medical device (nitrile examination gloves), not an AI/ML diagnostic or assistive tool.

6. 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 AI/ML algorithm.

7. The type of ground truth used
The ground truth is established by objective measurements and observations in accordance with standardized test methods (ASTM and ISO standards). For example:

• Physical Dimensions: Measured length and width of gloves.
• Thickness: Measured thickness at finger and palm.
• Physical Properties (Tensile Strength, Elongation): Mechanically tested to quantify material strength and stretch.
• Watertightness: Direct testing for leaks/holes.
• Powder Content: Quantified residue weight.
• Biocompatibility (Systemic Toxicity, Irritation, Sensitization): In vivo animal testing or in vitro assays as defined by ISO 10993 standards to observe biological reactions.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The manufacturing process is validated, not trained.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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