Welcome to Fitone Group, a prominent medical device company established in 2001 in southern China. We specialize in producing high-quality medical gloves, condoms, and face masks to meet the needs of healthcare professionals and individuals worldwide. With four production plants and almost 1600 employees, we cover a total area of 256,000 square meters, making us one of the largest medical device manufacturers in the industry.
Our commitment to quality is evident in our three trusted brands - Doctor Gu, ANDLASS, and FITONE - which are used by customers in over 70 countries worldwide. We have 20 production lines for making medical gloves and 12 advanced, eco-friendly production lines that use internal electric heating to make condoms, which are protected by patents. This enables us to produce 6 billion medical gloves and 1.8 billion top-notch condoms annually. Our company's annual revenue is a remarkable 3 billion RMB.
At Fitone Group, we are devoted to providing high-quality, dependable products and services that meet the changing needs of our customers. We aspire to be an innovative, socially responsible, and customer-focused company that makes a positive impact on the global community. Thank you for selecting Fitone Group as your trusted partner in the medical device industry.
Personal Protective Equipment (PPE) Regulation refers to a set of regulations designed to ensure that personal protective equipment, such as gloves, safety glasses, masks, and other gear, are appropriately designed, manufactured, tested, and labeled. These regulations are intended to ensure that PPE protects the wearer against potential health and safety risks in the workplace.
Disposable medical gloves are essential in the healthcare industry, offering protection for both healthcare professionals and patients. However, it's crucial to understand that not all disposable medical gloves are created equal. Different standards and regulations govern the manufacture and use of disposable medical gloves, ensuring that they meet the appropriate safety and performance criteria. In this article, we will explore the different standards and regulations for disposable medical gloves and why they matter.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), many medical gloves are required to undergo premarket notification in accordance with section 510(k). Further details on this can be found in the Premarket Notification 510(k) document. The FDA's regulations apply to various types of medical gloves, as listed in the table below.
Healthcare workers use medical gloves to prevent the transmission of microorganisms that can cause infections or illnesses. Medical gloves are designed to be disposable and include different types such as patient examination gloves, surgeon's gloves, and chemotherapy gloves. To help you use disposable medical gloves correctly in healthcare settings, we have gathered information in the "Glove Use Information Leaflet."