(43 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powdered Latex Medical Examination Gloves with 150 Micrograms or Less of Total Water Extractable Protein per Gram of Glove.
This document is an FDA 510(k) clearance letter for Powdered Latex Medical Examination Gloves. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, but does not provide specific data from performance studies.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.