(213 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Synthetic Vinyl Patient Examination Gloves, White
This document (K031170) is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria.
The acceptance criteria typically refer to performance metrics (e.g., sensitivity, specificity, accuracy) that a medical device must achieve in a clinical study to be considered safe and effective for its intended use. This document is a regulatory approval notice, indicating that the device is substantially equivalent to legally marketed predicate devices, not a study report.
Therefore, I cannot extract the requested information from 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.