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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, PowderFree, Non-Sterile

This document is an FDA 510(k) clearance letter for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It explicitly states that the device is substantially equivalent to legally marketed predicate devices and does not require approval of a Premarket Approval Application (PMA).

However, the provided text does not contain any information about acceptance criteria, a study, or performance data for the device. The letter is an administrative notification of clearance based on equivalence, not a detailed report of a device's performance against specific criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set.
• Data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250) .

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

This document is a 510(k) clearance letter from the FDA for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It grants market clearance based on substantial equivalence to existing devices. As such, it does not contain the detailed study information regarding acceptance criteria and performance of a new medical device that you're looking for.

Instead, this letter confirms that the device is a Class I medical device and is subject to general controls. For these types of devices, performance testing often focuses on established standards (e.g., ASTM standards for gloves) and equivalence rather than complex clinical studies with ground truth establishment and MRMC analysis.

Therefore, I cannot extract the information you requested from this document. The document primarily focuses on regulatory clearance, not detailed device performance study results.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile

This document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily addresses regulatory approval and does NOT contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device