(82 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.
Pre-Powdered Multi-ply Latex Patient Examination Glove (Natural Rubber Latex-Nitrile-Construction) with Protein Content labeling claim 68.25 micrograms or less per gram of gloves.
I am sorry, but the provided text from the FDA 510(k) notification for the "Health-Plus Sanitex, Reliance Pre-Powdered Multi-Ply Latex Examination Glove" is a regulatory clearance document. It confirms that the device is substantially equivalent to a predicate device and can be marketed.
This document does not contain any information regarding:
- Acceptance criteria or reported device performance beyond the protein content claim.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
The 510(k) process for a Class I medical device like an examination glove primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through performance standards or existing regulatory frameworks, rather than detailed clinical studies with the kind of methodology described in your request. The protein content claim of "68.25 micrograms or less per glove" is a single performance characteristic mentioned, but no study details are provided in this regulatory letter itself.
§ 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.