(59 days)
A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile
This document is a 510(k) clearance letter from the FDA for Nitrile Patient Examination Gloves. It focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed performance studies with acceptance criteria for a new AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device is not contained in the provided text.
The document does include:
- Device Name: Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile (later specified as RS Nitrilstat Medical Examination Gloves, Powdered (Non-Sterile)).
- Applicant: Riverstone Resources Sdn. Bhd.
- Intended Use: "A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient."
Without a document detailing the performance study for such a device, I cannot fulfill the request.
§ 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.