(110 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.
Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less
I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less." It primarily discusses the regulatory approval of the glove and its classification.
This document does not contain any information about:
- Acceptance criteria or device performance data for an AI/ML medical device.
- Study details such as sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent 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.