(48 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes the submission for a Powder Free Vinyl Patient Examination Glove and does not contain information about an Artificial Intelligence (AI) device or a study that uses AI. Therefore, I cannot generate the requested information regarding AI device acceptance criteria, performance, or study details.
The document discusses the substantial equivalence of the glove to a predicate device based on physical and dimension testing (ASTM-D-5250-00 e4), a water fill test, primary skin irritation and sensitization testing, and a residual powder test. These are standard tests for medical gloves, not AI systems.
Therefore, the table and other detailed points you requested about AI device performance and studies cannot be extracted 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.