(151 days)
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green 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 - Lemon Green
The provided text describes an FDA 510(k) clearance for "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green." This document is a regulatory approval for a medical device (patient examination gloves). It does NOT contain information about an AI/ML-based medical device, a study proving device performance against acceptance criteria for an AI/ML system, or details about the development and testing of an AI algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment the way you would for an AI/ML device.
The information in the provided text relates to:
- Device Name: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
- Regulation Number: 21 CFR 880.6250 (Patient Examination Glove)
- Regulatory Class: Class I
- Product Code: LZA
- Indications for Use: Non-sterile disposable device intended for medical purpose, worn on the examiner's hand to prevent contamination between patient and examiner.
- Use Type: Over-The-Counter Use
This is a clearance for a physical medical device, not a software or AI/ML-based device. If you have a different document describing an AI/ML device and its validation study, please provide that text.
§ 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.