(62 days)
Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.
LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less)
I am sorry, but the provided text does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for "TG Medical Powder-Free Latex Examination Glove," which primarily addresses regulatory equivalence to a predicate device. It explicitly states that "this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations."
Therefore, I cannot fulfill your request based on the provided input.
§ 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.