(108 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.
Powder - Free Patient Examination Glove
I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves" and an "Indications For Use" statement.
This document does not include any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how ground truth was established for it.
The document is solely a clearance letter stating that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. It does not delve into the specific performance metrics or studies you are asking for.
§ 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.