(277 days)
A powder-free, non-sterile patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES.
The provided document is a 510(k) premarket notification letter from the FDA to Quality Gallant SDN. BHD. regarding "Powder Free Nitrile (Dark Blue) Examination Gloves." This letter primarily addresses the regulatory approval of the device and its substantial equivalence to legally marketed predicate devices.
Crucially, this document does not contain information about acceptance criteria for a device's performance beyond regulatory requirements, nor does it detail a study that proves the device meets specific performance-based acceptance criteria in the context of a medical AI or diagnostic device. It focuses on the regulatory classification, general controls, and good manufacturing practices for examination gloves.
Therefore, I cannot provide the requested information from the provided text, as the document does not describe:
- A table of acceptance criteria and reported device performance: The document only lists the device name, regulation number, and regulatory class. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any other quantitative measures typically found in performance studies.
- Sample size for the test set or data provenance: No performance testing data is presented.
- Number of experts and their qualifications for ground truth: Not applicable, as there's no diagnostic performance study mentioned.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device (gloves), not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The "Indications for Use" section (page 3) defines the intended use of the gloves but does not include performance criteria or the results of studies demonstrating their fulfillment beyond the inherent properties of medical examination gloves.
In summary, the provided text concerns the regulatory clearance of medical examination gloves and does not offer the type of performance study details requested for an AI or diagnostic device.
§ 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.