K Number
K993221
Date Cleared
1999-11-05

(39 days)

Product Code
Regulation Number
880.6250
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

Device Description

LATEX EXAMINATION GLOVES, PREPOWDERED

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA to a medical device company and an "Indications for Use" statement. It communicates that the company's "Latex Examination Gloves Prepowdered" have been determined to be substantially equivalent to devices marketed before 1976 and can therefore be marketed.

This document does not contain information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as your request asks for.

Therefore, I cannot fulfill your request 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.