(87 days)
A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
The provided text is a 510(k) premarket notification approval letter for "Polymer Coated Chlorinated, Powder-Free Latex Examination Gloves with Protein Labeling (50 ug/g or Less)". It states that the device is substantially equivalent to a legally marketed predicate device.
However, this document does not contain information about acceptance criteria, specific device performance data, a study design, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked for a typical AI/ML medical device submission.
The text focuses on regulatory approval based on substantial equivalence, general controls, and compliance with federal regulations. It does not elaborate on a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML device evaluations.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and performance metrics as they are not present in the provided document.
§ 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.