(120 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.
Latex powdered patient examination gloves with 70 mcgm or less of total water extractable protein per gram
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for "Supergloves, Latex Powdered Exam Gloves" and an "Indications for Use" statement.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not include performance data, study designs, sample sizes, or information about expert ground truth determination. The "Indications For Use" section simply states the purpose of the medical examination glove.
§ 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.