(63 days)
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Kleenhands Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Kleenhands Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)".
This document is a regulatory approval letter, not a scientific study report. Therefore, it does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets them.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on ground truth types or how ground truth was established for training or test sets.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device (the gloves) is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications For Use" section on page 2 defines what the gloves are for ("A medical or a patient examination glove is a disposable device worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.") and mentions a "PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)", which is a characteristic of the product, but not an acceptance criterion in the context of a performance study.
To answer your prompt, you would need a different type of document, such as a clinical study report or a technical performance evaluation report for an AI/CAD diagnostic device.
§ 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.