(42 days)
A Patient Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Pouderfree Blue Nitrile Examination Gloves Polymer Coated
This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as requested in your prompt. This type of regulatory clearance letter typically confirms substantial equivalence based on comparisons to existing devices, and often refers to supporting data previously submitted, but does not present the study details itself.
§ 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.