(88 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein label claim (50 microgram or less)
This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device, "Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein Labeling Claim (50 Micrograms or Less)," is substantially equivalent to legally marketed predicate devices, which allows it to proceed to market.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for establishing ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This type of information is typically found in a clinical study report or a more detailed technical submission, not in the FDA clearance letter itself.
§ 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.