(77 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger prevent contamination between patient and to examiner.
Powder-Free Green Nitrile Examination Gloves (Polymer Coated)
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Green Nitrile Examination Gloves." This letter grants market clearance based on substantial equivalence to a predicate device, focusing on regulatory compliance rather than detailed performance study results against specific acceptance criteria for a new and complex AI/software device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available within the provided FDA clearance letter. These types of details are typically found in the technical documentation submitted by the manufacturer, which is not part of this output.
The FDA letter confirms:
- Device Name: Powder-Free Green Nitrile Examination Gloves (Polymer Coated)
- Regulatory Class: I
- Product Code: LZA
- Indications For Use: "A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger prevent contamination between patient and to examiner."
- The device was found substantially equivalent to legally marketed predicate devices.
This document does not contain the level of detail requested for a comprehensive performance study analysis.
§ 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.