(50 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of
This document is an FDA 510(k) clearance letter for "Powderfree Latex Examination Gloves (Protein Trade Name: Label Claim)." It is not a study that evaluates a medical device against acceptance criteria using performance data. Therefore, I cannot extract the requested information.
The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. It does not contain any details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.
§ 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.