(37 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Latex Patient Examination Gloves (Pre-powdered)
The provided text is related to a 510(k) premarket notification for "Latex Examination Gloves (Pre Powdered)" from USG HealthGuard Sdn. Bhd. It's an FDA clearance letter from 1999, not a study evaluating a medical device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided document.
This document merely confirms that the FDA reviewed the 510(k) notification and determined the device (Latex Examination Gloves) is substantially equivalent to devices marketed before May 28, 1976. It does not contain any performance studies, acceptance criteria for device performance, or details on clinical trials or AI evaluation.
To answer your request, I would need a document describing a performance study of a device, including its acceptance criteria and 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.