(15 days)
Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free WITH PROTEIN LABELING CLAIM (100 mic
The provided text is a 510(k) clearance letter from the FDA for medical examination gloves. It does not describe a study or acceptance criteria for a device in the context of AI/ML performance. Instead, it concerns the substantial equivalence of a physical medical device (gloves) to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as these concepts are not applicable to the content of 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.