(205 days)
The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.
The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.
The provided text is an FDA 510(k) clearance letter for a medical device: "Powder Free Vinyl Patient Examination Glove." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria for a diagnostic algorithm or AI-powered medical device.
The letter explicitly states:
- Device Name: Powder Free Vinyl Patient Examination Glove
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: Class I, reserved
- Product Code: LYZ
This is a physical, disposable medical glove, not a diagnostic algorithm or an AI system. The 510(k) clearance for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance standards for physical properties, biocompatibility, and manufacturing processes, rather than the type of clinical study outlined in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment for AI/diagnostic devices).
Therefore, I cannot fulfill your request using the provided text because it describes a completely different type of medical device and does not include the information you've asked for regarding acceptance criteria and performance studies for an AI or diagnostic algorithm.
§ 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.