(87 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.
Chlorinated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per gram.
The provided document (K013498) is a 510(k) premarket notification letter from the FDA regarding "Chlorinated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval letter and does not contain information about acceptance criteria or studies proving a device meets acceptance criteria in the context of a modern AI/ML medical device.
The information requested, such as a table of "acceptance criteria and reported device performance," "sample sizes for test set and training set," "ground truth establishment," "MRMC studies," etc., are typical requirements for evaluating the performance of AI/ML-driven medical devices or diagnostic tools.
The document pertains to a physical medical device (examination gloves) and its approval is based on a "substantial equivalence" determination to legally marketed predicate devices, rather than a performance study involving statistical metrics common for AI/ML.
Therefore, it is not possible to answer the requested questions based on the provided text, as the document does not describe such studies or criteria.
§ 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.