(25 days)
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powdered Examination Gloves (Blue)
This document is a 510(k) clearance letter from the FDA for Nitrile Powdered Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to a legally marketed predicate device.
However, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance metrics of an AI/ML powered medical device.
The provided text only includes:
- Device Name: Nitrile Powdered Examination Gloves (Blue)
- Regulation Number/Name: 21 CFR 880.6250, Patient Examination Glove, Regulatory Class: I
- Product Code: LZA
- Indications For Use: "The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."
To answer the detailed questions about acceptance criteria and study design, a different type of document, such as a summary of safety and effectiveness, clinical study report, or a comprehensive 510(k) submission document (which often contains such details in the body of the submission), would be necessary.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided 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.