(69 days)
The Ostar D'Pro glove is a disposable patient examination The Ostal D ITO glove the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Ostar D'Pro Latex Powdered Examination Gloves, Protein Claim of 100 mcgm or less of Total Water Extractable Protein Per Gram
This document is a marketing clearance letter from the FDA for a medical device (Ostar D'Pro Latex Powdered Examination Gloves) and does not contain information about acceptance criteria or a study proving the device meets these criteria. It primarily discusses the substantial equivalence of the device to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the input text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set or how its 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.