medical nitrile gloves 510k medical device description pdf

June 2020 510(K) Clearances | FDA

06-07-2020·SE DECISION MADE: 03-JUN-20 Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FiteBac Antimicrobial Cavity Cleanser Largent Health, LLC 510(k) NO: K200614(Traditional) ATTN: Kirk ...

FDA Permanently Exempts Seven Class I Gloves from 510(k ...

28-01-2021·Through the Notice, HHS identified seven class I devices—all medical gloves—as exempt from the 510(k) premarket notification requirements. The newly exempt gloves include: Device Description

List of Global Medical Device Nomenclature (GMDN) …

03-08-2018·The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term. 01 Active implantable devices. 02 Anaesthetic and respiratory devices. 03 Dental devices. 04 Electro-mechanical devices. 05 Hospital hardware.

USA: FDA 510(k) permanent exemption for certain Medical ...

22-02-2021·In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA published a notice in the Federal Register which highlights the relaxation of numerous regulatory, including a waiver of Premarket Notification 510(k) requirements, that is, the Premarket notification requirements under section 510(k).

Malaysia Medical GLOVE (HARTALEGA -EUREKA)

glove Product Code Product Description Colour Product Conformance Packing Method Speci Ications ... This is to certify that. in accordance with the Medical Device Directive 93/42/EEC, Medical Device Safety Service GmbH (MDSS) ... powder Free Nitrile Examination Gloves Malaysia Med i um Pow der Con tent EN455 Part 32015

Clinical review: Examination gloves

Both sterile and non-sterile examination gloves are class 1 medical devices under the MHRA classification of medical devices system. As such they have been subject to the conditions and regulations applied throughout the European Union under MDD 93/42EC which has now been replaced by MDR 2017/745 (2017).

Nitrile Glove - The World's Largest Manufacturer of Gloves

NITRILE EXAMINATION GLOVE. Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K)

PowerPoint Presentation

medical device pursuant to the Medical Devices Act 2008. The following products may be sold in Thailand and exported without restriction. Name of Products Latex Powdered Examination Gloves Latex Powder Free Examination Gloves Nitrile Examination Gloves This certificate is issued upon the request of Mercator Medical (Thailand), Ltd. Thailand. a

Understanding glove certification

All KIMTECH SCIENCE* gloves are PPE Category III certified and compliant with Medical Device standards EN455-1,-2,-3,-4 Protection level against risks Biohazard EN374-1:2003 EN374-1:2003 Virus protection EN374-1: 2003 Material Product code Description EN374-2: 2003 EN374-2: 2003 Level 3 Level 2 0.65 1.5 1.5 1.5 ISO 16604: 2004 Proc. B

General Features and Specifications of Nitrile Gloves, by ...

Medical gloves are disposable gloves used during medical examinations and procedures that help prevent contamination between caregivers and patients.[1] Medical gloves are made of different polymers including latex, nitrile rubber, vinyl and neoprene; they come unpowdered, or powdered with cornstarch to lubricate the gloves, making them easier to put on the hands.[2]

Nitrile Glove - The World's Largest Manufacturer of Gloves

NITRILE EXAMINATION GLOVE. Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K)

Ansell EDGE® 82-133 Disposable Nitrile Glove

Ansell EDGE®  82-133 / 82-135 Disposable Nitrile Glove, FDA 21, EN 374, EN420, ASTM D6319, ISO 9001, ISO 13485, CE, 100% LC. It fulfills all food contact and medical requirements including the European, USA and International standards.Our Nitrile Glove offers the best combination of extrem

FDA Advisory No. 2020-1506 || Public Health Warning ...

FDA Advisory No. 2020-1506 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE” Share this Post! The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

Clinical review: Examination gloves

Both sterile and non-sterile examination gloves are class 1 medical devices under the MHRA classification of medical devices system. As such they have been subject to the conditions and regulations applied throughout the European Union under MDD 93/42EC which has now been replaced by MDR 2017/745 (2017).