DISPOSABLE MEDICAL FACE MASKS
TRN MODA, who wants to carry its experience in the field of ready-to-wear to the field of medical textile products, started to produce sterile and non-sterile disposable Type IIR surgical masks under the TRN MedTeks brand in its own facility established in an additional 2000 m2.
Medical surgical face masks are designed to be used in operating rooms , or in the areas which the healt services are given with similar requirements to medical environments and to protect whole working environment .
The EN 14683 standard defines two types of medical surgical face masks with associated levels of protection.
As a minimum, Type I medical face masks are used for patients to reduce the risk of spreading infections in the community, especially in epidemic or pandemic situations.
Type II masks are primarily designed for use by healthcare professionals in an operating room or other medical areas with similar requirements of operating rooms.
Type II R masks are designed for use in surgeries and situations with splash risk.
Regarding microbial cleaning, the biological burden of our masks in our production; it has been evaluated according to Annex D of the ISO 14683 standard or according to the EN ISO 11737-1 standard.
In addition, our masks have been tested according to EN ISO 10993-1 standard and evaluated with clinical requests.
Considering the place and time of contact with the body, it becomes necessary to perform physical and chemical evaluation, cytotoxicity, irritation and sensitization tests.
Medical surgical face masks that are not in sterile condition are classified as Class I according to 93/42 / EC regulation Medical surgical face masks in sterile condition according to 93/42 / EC directive, is considered a class I device (class Is). In this case, in addition to the above steps, a notified body certification will be required in the 93/42 / EC directive. Our company has ISO 13485 and CE certificates.