(33 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.
I am sorry. I cannot fulfill this request. The provided text describes the safety and effectiveness of latex examination gloves, which is a medical device, but it lacks the specific information required to address your questions about acceptance criteria for an AI/ML powered medical device. The text does not mention any AI or machine learning components, nor does it detail studies involving human readers or ground truth established by experts in the context of AI.
§ 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.