(20 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potentially infectious and other contaminants.
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material.
The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves. It is not a study report for an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to the content of this document.
The document states:
- Device Name: Emerald Medical, Inc. Syntheticare Powder-Free Vinyl Patient Examination Gloves
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I
- Product Code: LYZ
This type of device (patient examination gloves) is a physical medical product, not a software or AI-driven diagnostic device. The FDA's decision is based on substantial equivalence to a legally marketed predicate device, rather than a clinical study demonstrating performance against specific acceptance criteria for an AI algorithm.
To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical device.
§ 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.