FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene 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.

Device Description

Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene Examination Glove

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document appears to be an FDA 510(k) clearance letter for a medical glove, focusing on regulatory aspects, indications for use, and substantial equivalence to a predicate device. It does not include details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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K Number

K011446

Device Name

BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

Manufacturer

BARRIERMED, INC.

Date Cleared

2001-06-14

(34 days)

Product Code