(75 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
Powdered Nitrile Examination Gloves
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves." This document is a regulatory communication, not a scientific study report describing device performance or acceptance criteria in the typical sense of a clinical or performance study of an AI/software device.
Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from the provided text.
The document states that the device is "substantially equivalent" to predicate devices, meaning it has sufficiently similar characteristics and indications for use as a device already legally marketed. For examination gloves, the "performance" typically refers to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes), which are usually tested against established international standards (like ASTM or ISO standards for medical gloves). The 510(k) process involves demonstrating compliance with these standards, but the detailed results of those tests are not typically included in the final clearance letter itself.
The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or human-AI improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is concerned with the regulatory clearance of a physical medical device (examination gloves), not a software or AI-driven diagnostic or therapeutic device that would undergo the types of studies described in your prompt.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.