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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, white (non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

The provided text is related to a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves," not an AI-powered medical device study. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant information about the device's performance based on the provided document:

Acceptance Criteria and Device Performance

Study Details (where applicable based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. The document discusses device characteristics and meeting standards, not a test set in the context of an AI study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to this product. The 'ground truth' here refers to whether the glove met the specified standards.
3. Adjudication method for the test set: Not applicable. The "adjudication method" is not relevant to the described testing of physical characteristics and biocompatibility.
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 is a medical device (gloves), not an AI system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (gloves), not an AI system.
6. The type of ground truth used: The 'ground truth' for the device was defined by established regulatory standards and test methods, such as ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10 for physical properties and biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Further Explanation of the Study:

The document describes a premarket notification (510(k)) where the manufacturer seeks to demonstrate that their "Powder Free Vinyl Patient Examination Gloves" are substantially equivalent to a legally marketed predicate device. This is achieved by showing that the new device meets established industry standards and FDA regulations for physical properties, freedom from pinholes, powder residual, and biocompatibility.

The "study" in this context refers to the non-clinical testing performed to demonstrate compliance with these standards. The testing methods mentioned are:

• ASTM standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
• 21 CFR 800.20: For Freedom from pinholes (waterleak test).
• ISO10993-10 / Primary Skin Irritation in rabbits: For Biocompatibility.
• ISO10993-10 / Dermal sensitization in the guinea pig: For Biocompatibility.

The conclusions from these non-clinical tests were that the Blue Sail (Brand) Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements as detailed in the table above. Clinical data was explicitly stated as "not needed for gloves or for most devices cleared by the 510(k) process" for this type of device.

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