(63 days)
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN QU THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN THE HEALTH CARE PERSONNEL AND THE PATIENT.
Kleenhands Powdered Latex Examination Gloves
The provided text is a letter from the FDA regarding the clearance of "Kleenhands Powdered Latex Examination Gloves" and an "Indications for Use" statement. It approves the marketing of the device but does not contain acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies.
§ 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.