(50 days)
Midas Touch™ Blue Latex Examination Gloves - 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™ Blue Latex Examination Gloves – Powder free
The provided text is an FDA 510(k) clearance letter for examination gloves. This type of document does not describe acceptance criteria, study details, or performance metrics for AI/ML-driven devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training or test sets.
The document confirms the device (Midas Touch™ Blue Latex Examination Gloves, Powder Free) is substantially equivalent to legally marketed predicate devices, meaning it meets the general controls provisions for Class I devices. The indications for use are described as: "a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner." This is a regulatory assessment for a physical medical device, not an AI/ML software 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.