(156 days)
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Lemon Green (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - White (Lavender Scent); Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - Dawn Blue (Lavender Scent) and Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - Lemon Green (Lavender Scent)
The provided document is a 510(k) premarket notification decision letter from the FDA for Nitrile Powder Free Examination Gloves with Colloidal Oatmeal Skin Protectant. This document does not contain information about a study proving a device meets acceptance criteria. Instead, it is a regulatory approval document confirming substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from this document as it does not describe such a study.
§ 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.