LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)

• K Number: K991950
• Device Name: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
• Manufacturer: LAGLOVE (M) SDN. BHD.
• Date Cleared: 1999-08-12 ( 64 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worn by operating personnel during surgical procedures to help prevent contamination between health-care personnel and the patient.

Device Description

disposable glove made of synthetic rubber

AI/ML Overview

This document is a marketing clearance letter from the FDA for Laglove™ Brand Nitrile Surgical Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer the question based on the provided text.

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).