(56 days)
Pepper Green Mint Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
The provided document is a 510(k) clearance letter from the FDA for "Pepper Green Mint Powdered Latex Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory clearance for a medical device (gloves), not a performance study or a report on AI/software device validation.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.
§ 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.