(47 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Ansell Perry Incorporated for "Dermaclean X-AM™ Powder-Free Latex, Examination Gloves with Protein Labeling Claim." This document does not describe the acceptance criteria and a study proving the device meets those criteria.
Instead, it's a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device. It confirms the device's classification and allows the applicant to market it. The "Indications For Use" section merely states the intended purpose of the gloves.
Therefore, I cannot provide the requested information because the document does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets or data provenance.
- Information on experts used to establish ground truth or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Details about the training set size or how its ground truth was established.
§ 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.