(102 days)
The Nitrile Powder Free Examination Gloves -Violet Blue (VBLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Nitrile Powder Free Examination Gloves - Dak Blue (DKBU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Nittle Powder Free Examination Gloves - Aqua Blue (ABLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Gloves- Aqua Blue (ABLU) Nitrile Powder Free Examination Gloves- Violet Blue (VBLU) Nitrile Powder Free Examination Gloves- Dark Blue (DKBU)
This document is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves. It details the indications for use of the gloves but does not contain information regarding detailed acceptance criteria or the specific studies used to demonstrate device performance against such criteria.
The document primarily focuses on:
- Regulatory Clearance: Acknowledging the review of the 510(k) application and determining substantial equivalence to legally marketed predicate devices.
- Device Identification: Trade names (Aqua Blue, Violet Blue, Dark Blue), regulation number, regulation name, regulatory class, and product code.
- Indications for Use: Stating that the gloves are "a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
- Regulatory Compliance: Reminders about general controls provisions, potential additional controls, and contact information for further advice.
Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is a clearance letter and "Indications for Use" statement, not a detailed technical report or study summary.
§ 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.