(29 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
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
I am sorry, but the provided text is a Food and Drug Administration (FDA) clearance letter for a medical device, specifically "Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling."
This document does not contain the information required to answer your request about acceptance criteria and a study proving device performance.
The letter focuses on:
- Confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
- Outlining regulatory requirements and general controls provisions.
- Providing contact information for further guidance.
- Stating the intended use of the gloves.
There is no mention of:
- Specific acceptance criteria for performance.
- Any study data, sample sizes, data provenance.
- Expert involvement for ground truth, adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot generate the requested table or answer the specific questions based on the provided input.
§ 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.