The disposable glove is one of the most important personal protective equipment. They protect the professional and patients from chemicals and contamination by germs and bacteria. These types of gloves are ideal for activities that require protection without losing touch and/or sensitivity of the hands.
One of the options available on the market is the vinyl glove. The vinyl glove is hypoallergenic, latex-free, and is indicated to meet the replacement cases of natural rubber gloves.
It is indicated in some procedures within the hall, according to its strength, texture and durability. In this post, we explain everything about vinyl glove, its applications, care and more. To find out all about it, just continue with the reading!
The vinyl glove is composed of vinyl resin, that is, there is no presence of latex. This makes the vinyl glove ideal for hypoallergenic or material-sensitivepeople.
Vinyl gloves are indicated for some medical or dental procedures, for food handling, in some industrial applications and in aesthetic procedures. Because they are not made of latex, vinyl gloves ensure more agility in movements, besides being much more resistant.
It is necessary to understand that, in order to perform the petitioning of products that are subject to sanitary surveillance, those that may offer health risks, it is mandatory to regularize the company responsible for manufacturing and distributing such products.
If you find it difficult to adapt your company or product under current legislations acquire a regulatory consultancy.
Stone Okamont specializes in company and product regularization at ANVISA. Click on the link below and request your quote!
Veja what are the necessary steps to obtain the registration of vinyl gloves in ANVISA.
Step 1: Operating License
Before you file a vinyl gloves registration application with ANVISA, the first step is to obtain the Operating License for your establishment. It is acquired from a survey conducted by VISA, i.e. the Local Sanitary Surveillance.
Stone Okamont works with excellence in the preparation of the Operating License process with VISA.
The Operating License is an approval document with the local Sanitary Surveillance, recognizing that your establishment has technical and operational conditions to carry out your activity and take you to the next step that is the Company Operating Authorization.
Step 2: Company Operating Authorization
The Company Operating Authorization, better known as "AFE " is a document issued by ANVISA,published in the Official Gazette ofthe Union (DOU). It enables you to engage in the activity which has been petitioned with the Agency. Obtaining AFE means that the company operates in accordance with Brazilian legislation and is able to operate nationwide.
The "AFE" is necessary and indispensable for the next step that is the petitioning of the Product Registration.
Do I need to take the CBPF to get the product registration?
In the case of vinyl gloves registration there is no need to obtain the Certificate of Good Manufacturing Practices, since the product has its low risk rating (Risk Class I).
Step 3: Registro vinyl gloves
The Product Registration is the document issued by ANVISA legalizando comercialization of the same. From that moment on, the Agency will review the petition in the most appropriate way, verifying the documentation submitted to certify that thecompany is inaccordance with current legislation and able to develop its activities.
In this final step, product information such as: composition material, instructions for use, disposal instructions, and more arepresented. In this way, the petitioning process must be respected, and mandatory documentation must be attached and the petition must be filed with ANVISA.
Companies that offer products that may be harmfulto health, such as medicines, pesticides, cosmetics, etc.; they need to be up to date with all regularizations with ANVISA.
How can we help?
The regulatory affairs sector is responsible for the regularization of products and establishments. Stone Okamont has over 30 years of experience and expert consultants to help you and your company with excellence and extraordinary results.
Talk to people who understand! Count on Stone Okamont, we have a team of professionals trained in place to meet the needs of your company and product.
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