Nitrile examination/treatment glove, non-powdered - ARTG 390317
Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 390317 and sponsored by Cas Int'l Pty Ltd, manufactured by Zhonghong Pulin Medical Products Co Ltd in China. The device registration started on June 14, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The gloves are an effective means of protecting against infectious disease and are intended to be used with additional PPE as mandated in the Public Health Agencies Guidelines on infectious disease prevention and control. 1.How the gloves is to be used Correct Fitting Gloves: While wearing gloves, extend your fingers until they are straight. You will know your gloves are too small if the nitrile is stretching OR you see tears forming in the material where your thumb meets your palm. Properly put on Gloves: They absolute key when dealing with gloves and putting them on, is cleanliness. People should put on gloves in a clean area with clean hands. Do not touch the outside of the glove when put them on. An easy way to do this is first put the nitrile glove on the dominant hand, while touching it as little as possible. Then, put the other glove on the non-dominant hand, using gloved dominant hand to pull it on. Once both gloves are on hands , can adjust fingers and the fit of the glove. Properly Removing Gloves :when removing gloves , the hand skin should not touch the outside of the glove to avoid get unwanted liquids or substances on skin. 2.The circumstances in which the gloves would be used; Nitrile gloves protect against physical hazards. They provide the user with a physical barrier of protection between them and potential hazard. And the gloves prevent transmission of a wide variety of diseases to both patients and health care personnel. Specifically, gloves are intended to act as a barrier between the health care provider and patients to prevent contamination between patient and caregiver. The gloves can protect them from bacteria, viruses, microorganisms, bio-hazards, dirt… 3.limitations of the gloves: The gloves should not be used near an open flame or any material that has potential to ignite. Caution: Components used making Nitrile glove may cause allergic reactions in some people. If allergic reactions occur, discontinue use immediately and consult with physician. Storage Conditions :Store in a cool, dry place. Avoid excessive heat (40oC, 104oF). Shield open box from direct sun ,fluorescent light, x-ray machines ,other sources of ozone, heat and moisture.