(36 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Vinyl Synthetic Exam Gloves, White Color." This document does not describe a study that proves the device meets specific acceptance criteria in the way that an AI/ML medical device submission would.
Instead, this letter is a determination of "substantial equivalence" to a legally marketed predicate device, meaning the gloves are considered safe and effective for their intended use because they are similar to existing devices already on the market.
Therefore, I cannot provide the requested information as the document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set or how ground truth for training was established.
The "Indications For Use" section (page {2}) simply states the intended purpose of the gloves: "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER." This is not an acceptance criterion in the context of an AI/ML device study.
§ 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.