(133 days)
A powder free latex examination glove with vanilla, grape and strawberry flavor 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.
Flavoured, Powder Free And Polymer Coated Latex Examination Glove (Vanilla, Grape and Strawberry) With A Protein Claim Of Less Than 50ug/dm2
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance. The document is a 510(k) premarket notification from the FDA regarding "Flavored, Powder Free and Polymer Coated Latex Examination Glove". It primarily focuses on regulatory approval and substantial equivalence to existing devices, and does not include details on acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered medical device.
§ 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.