(43 days)
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
The provided text is a 510(k) Pre-market Notification communication from the FDA to Asia Pacific Latex Berhad regarding Nitrile Patient Examination Gloves, Powder-Free. It is not a study or report on the performance of an AI/ML medical device. Therefore, I cannot provide the requested information as the document does not contain any details about acceptance criteria, device performance, study design, expert involvement, or ground truth for an AI/ML device.
The document is a regulatory approval letter for a physical medical device (gloves), confirming it is substantially equivalent to existing devices.
§ 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.