Documentations are realted to products.
This section not only promotes the products but also gives the related literature and certification details and some times end user warnings and information for the products or categories of products.
Barrier Properties of Protective Clothing Once the hazard and the risks of exposure are identified, gown and coverall selection can be guided by current scientific understanding of how protective clothing materials provide protection against microorganisms in blood and body fluids. A microorganism’s movement through protective clothing materials depends upon several factors, including the following: Physical … Continue reading
Classifying Worker Exposure to Bloodborne Pathogens As with any type of personal protective equipment (PPE), the key to proper selection and use of gowns and coveralls is to understand the hazards and the risk of exposure. The Centers for Disease Control and Prevention (CDC) has categorized three primary routes of transmission: (i) contact (direct and … Continue reading
What is Surgical Mask (Face Mask)? A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, … Continue reading
What is Non-Surgical Gown? Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of … Continue reading
What is Surgical Isolation Gowns Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. As … Continue reading
What is Surgical Gown? A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer … Continue reading
For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This information may include: Sterilization method that will be used. A description of the method that will be used to … Continue reading
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown. The performance of gowns is tested using consensus standards: American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical … Continue reading
EN 14683:2005 Mask Classifier Standart This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infectivea gents from staff to patients and (in certain situations vice;versa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable … Continue reading
Below is the PDF Catalogue for 3 Ply Masks. As FDA is not classifying Surgical masks to Levels. European standards EN 14683:2005 is used to define the types of the products. The PDF file hosts the following type of products: Type I Products Type IR Products Type II Products Type IIR Products Also youcan select … Continue reading