(28 days)
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less
The provided document is a 510(k) clearance letter from the FDA for "Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labelling Claim, 50 Micrograms or Less." This letter is an administrative notice of substantial equivalence determination and does not contain information about acceptance criteria or a study proving that a device meets those criteria.
Therefore, I cannot answer your request based on the provided text. The document does not describe:
- Acceptance criteria for a device's performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it 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.