(50 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.
Omni Flex Nitrile Examination Glove, Powder Free, Blue
This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Omni Flex Nitrile Examination Glove. It is primarily a regulatory approval document and does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about specific studies (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set size, or how ground truth was established).
The "Indications For Use Statement" only describes the intended purpose of the glove (to prevent contamination between healthcare personnel and the patient) but does not include any performance metrics or study details.
Therefore, I cannot provide the requested information from this document.
§ 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.