(99 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.
Powdered Latex Examination Gloves
This document is a 510(k) premarket notification approval letter for Powdered Latex Examination Gloves manufactured by Servicom Services Sdn. Bhd. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.
Therefore, I cannot extract the requested information. The document is an FDA approval for a physical medical device (gloves), not a software or AI device that would undergo such testing and reporting in a 510(k) submission.
§ 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.