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A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less); VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)" and "VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves."

This document does not contain any information about acceptance criteria or a study proving device performance. It is an FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. The letter discusses regulatory classifications, general controls, and compliance requirements, but not specific performance metrics or study results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

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A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

The provided text is a letter from the FDA regarding a 510(k) clearance for "Dash, 'Vital Gard' Powderfree Blue Nitrile Examination Gloves." This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML medical device.

The document is a clearance letter for a medical glove, which is a physical product, not a software or AI/ML device. Therefore, the concepts outlined in the request (such as acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies) are not applicable to the content of this FDA letter.

Ask a specific question about this device

Ask a specific question about this device