(48 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
DERMAGRIP-G AND MULTIPLE CUSTOMER TRADE NAME GREEN COLOR, ALOE VERA COATED, LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS WATER EXTRACTABLE PROTEIN)
I am sorry, but based on the provided document, the information requested about acceptance criteria and the study that proves the device meets them, including details like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not available. This document is a 510(k) clearance letter for latex examination gloves, primarily focusing on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
§ 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.