(30 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.
Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor.
The provided document describes a 510(k) premarket notification for "Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor." It's a regulatory letter from the FDA affirming substantial equivalence to a predicate device.
Crucially, this document is a regulatory approval letter and does not contain the technical details of a study demonstrating the device meets specific acceptance criteria, nor does it report performance metrics from such a study.
Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not the results of a scientific study evaluating the device's performance against detailed acceptance criteria.
To elaborate on why the requested information cannot be extracted from this document:
- Acceptance Criteria & Device Performance: The document does not list any quantitative or qualitative acceptance criteria for the gloves' performance (e.g., tensile strength, barrier integrity, tear resistance, flavor potency). It also does not report any test results for these or other parameters.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication): There is no mention of any study design, sample sizes for test or training sets, data provenance, number or qualifications of experts, or methods for establishing ground truth or adjudication.
- MRMC or Standalone Studies: No information is provided about multi-reader multi-case studies or standalone algorithm performance, as these concepts are not applicable to a physical medical examination glove.
- Training Set: The concept of a "training set" is relevant to machine learning models, not to physical medical devices like gloves.
In summary, the provided text is a regulatory communication, not a scientific study report.
§ 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.