(30 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
POWDER FREE NITRILE EXAMINATION GLOVES, Blue
The provided document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Blue". This type of document generally does not contain the detailed study information or acceptance criteria as requested in the prompt.
FDA 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, not necessarily on specific performance studies with detailed acceptance criteria as one would find for a novel diagnostic or AI-powered medical device. The letter confirms that the device meets the general controls provisions of the Act and is classified as Class I.
Therefore, I cannot extract the requested information from this document. The prompt asks for details like:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC study details and effect size
- Standalone performance
- Type of ground truth used
- Training set sample size and ground truth establishment
None of these details are typically included in an FDA 510(k) clearance letter for a Class I medical glove. These details would be part of a submission for a more complex device, especially those involving algorithms or advanced functionality.
§ 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.