(64 days)
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.
The document is an FDA 510(k) clearance letter for "SUPERGLOVES® Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)". It confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The letter mentions general controls provisions and regulatory requirements but does not include any performance study data or detailed acceptance criteria.
The "Indications for Use" section defines what the gloves are for, but it does not contain any performance metrics or criteria.
§ 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.