(168 days)
A 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.
LATEX EXAMINATION GLOVE POWDER FREE
This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).
This document is solely an approval letter for a medical device that falls under general controls.
§ 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.