(113 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN)
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for examination gloves. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. Therefore, I cannot fulfill your request based on the given context.
§ 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.