(78 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
Powdered Patient Nitrile Examination Gloves (White / Blue color)
The provided document is an FDA 510(k) clearance letter for "Powdered Patient Nitrile Examination Gloves (White/Blue Color)." This document does not contain information about acceptance criteria or a study proving that a device (in the sense of a software algorithm or diagnostic tool) meets acceptance criteria.
The letter pertains to the substantial equivalence of a physical medical device (gloves), and therefore the questions about algorithm performance, ground truth, expert review, sample sizes for training/test sets, and MRMC studies are not applicable.
The document states:
- Device Name: Powdered Patient Nitrile Examination Gloves (White/Blue Color)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Product Code: LZA
- Indications for Use: A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.
This is a regulatory clearance for a physical product, not a software or AI-driven diagnostic device. Therefore, the requested information (table of performance, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) is not present in this type of document.
§ 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.