(16 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient
Powder Free Polymer Coated Latex Examination Glove
This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Polymer Coated Latex Examination Gloves". It does not describe acceptance criteria for a study or provide data on device performance. Instead, it indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) from this document.
§ 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.