(14 days)
As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powder-Free Latex Examination Glove, Teal or White (non-colored)
The provided document is a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means it has met the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
Therefore, I cannot provide the requested information based on the content of these pages. The document does not describe:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This is typical for a 510(k) clearance letter for a Class I device like gloves, as extensive clinical studies are often not required if substantial equivalence to a predicate device can be demonstrated through other means (e.g., material testing, manufacturing process, intended use).
§ 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.