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K Number
K062950
Device Name
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2006-12-21

(83 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A Powder Free Surgeon's Glove made of synthetic material. It is intended to be worn by health.care personnel, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants.

Device Description

Powder Free Sterile Nitrile Surgical Gloves (Blue)

AI/ML Overview

This document is an FDA 510(k) clearance letter for Powder Free Sterile Nitrile Surgical Gloves (Blue). It does not contain information about acceptance criteria for a study, device performance, sample sizes, expert involvement, or grand truth. Therefore, I cannot answer the questions based on the provided text.

§ 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).