(61 days)
A medical glove is worn on the hand. of health care and similar personnel to prevent contamination between healthcare personnel and the patient.
Tekmedic Powder-Free LATEX Examination Gloves
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices like AI algorithms or diagnostic tools. The content focuses on regulatory compliance for a Class I medical device (Powder-Free Latex Patient Examination Gloves).
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or expert qualifications because it is not present in the provided text.
§ 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.