ELASTYLON POWDER-FREE SURGICAL GLOVE

• K Number: K984337
• Device Name: ELASTYLON POWDER-FREE SURGICAL GLOVE
• Manufacturer: ECI MEDICAL TECHNOLOGIES, INC.
• Date Cleared: 1999-04-09 ( 127 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A surgical glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Elastylon ® Powder-Free Surgical Glove

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms substantial equivalence of the "Elastylon Powder-Free Surgical Glove" to a legally marketed predicate device, enabling its market entry. Therefore, I cannot extract the requested information from this document.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).