(67 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device: "Teh Loong Vinyl, Powder-Free Patient Examination Glove." It is not a study report, and therefore does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device is considered safe and effective because it is similar enough to existing devices that have already been cleared by the FDA. The letter does not describe any specific studies performed by the manufacturer to prove performance against acceptance criteria.
Therefore, I cannot provide the requested information based on 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.