(78 days)
An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
POWDERFREE STERILE LATEX EXAMINATION GLOVES
This document is an FDA 510(k) clearance letter for Powder-free Sterile Latex Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically requested for AI/software device submissions.
The letter confirms general compliance with regulations applicable to Class I devices. The "Indications for Use" section simply defines what an examination glove is and its purpose, rather than establishing performance metrics.
Therefore, I cannot provide the requested information based on the provided text. The document is about regulatory clearance, not performance study results.
§ 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.