(31 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXIMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER
NITRILE EXAMINATION GLOVES -POWDER FREE
The provided document {0-2} is an FDA 510(k) clearance letter for "NITRILE EXAMINATION GLOVES -POWDER FREE." It does not describe any acceptance criteria or a study proving that the device meets those criteria.
The document indicates that the device 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." The FDA has determined that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This substantial equivalence determination means the FDA did not require a new clinical study to assess its safety and effectiveness.
Therefore, I cannot provide the requested information about acceptance criteria or a study from this document. The document primarily focuses on regulatory clearance based on substantial equivalence.
§ 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.