(70 days)
A medical glove is worn on the hand of A medical grow similar personnel to prevent contamination between health care personnel and the patient.
Nitrilon™ Correct-Touch® Nitrile Powder-Trade Name: Free Examination Gloves
The provided document is a 510(k) clearance letter from the FDA for a Nitrile Powder-Free Examination Glove. It is not a study report or a technical document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use: "A medical glove is worn on the hand of medical or similar personnel to prevent contamination between health care personnel and the patient."
The document does not contain any of the specific information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
§ 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.