(342 days)
A powder-free latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.
Disposable Latex Powder Free Examination Gloves (Non-sterile)
The provided document is a 510(k) clearance letter from the FDA for "Disposable Latex Powder Free Examination Gloves (Non-sterile)". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document, not a scientific study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is solely focused on the regulatory clearance process for a medical device (gloves), confirming its substantial equivalence to legally marketed predicates. It does not delve into the detailed performance study data you are seeking.
§ 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.