(125 days)
Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.
Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for Midas Touch Blue Latex Examination Gloves, confirming substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and marketing permissions. Therefore, I cannot fulfill your request based on the given input.
§ 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.