Description

GE Additive Community Face Mask Collection Label: PN4212AS0294-1-AM GE ADDITIVE FACE MASK COLLECTION See the attached Technical Data Package in the Documentation tab for detailed manufacturing and use instructions. This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects. Simple DIY mask with flexible filter media options. Three sizes available; small, medium and large. Each one can be printed in less than 15 minutes. Use string, elastic cord, rubber bands, or other options to secure to head. Any FDM 3D printer can produce these frames. User can select filter material to be used, (Cotton, Air filter, Rag, Hayland H600 etc.) Anchors around the frame are very handy to wrap string around for a snug fit. Mask frame will conform under tension, or can be heated and formed to the face. ****Ultimate goal is a low cost, fast printing, simple face mask with flexible filter material options that could be reused or discarded.**** "Make everything as simple as possible, but not simpler." Einstein PRECAUTIONS: THIS ITEM IS INTENDED FOR REUSE PROVIDED THAT IT IS PROPERLY DISINFECTED BETWEEN EACH USE BY APPLYING CLEANSER FOR DISINFECTING PLASTIC PRODUCTS (E.G. CAVICIDE) AND WASHING OR REPLACING FILTER MATERIALS AND ELASTIC BANDS IN ACCORDANCE WITH USER INSTRUCTIONS. NON-CLOTH FILTER MATERIALS SHOULD NOT BE PLACED DIRECTLY IN CONTACT WITH SKIN. NON-CLOTH FILTER MATERIALS SHOULD NOT CONTAIN FIBERGLASS. ADVERSE REACTIONS : EXTENDED USE OF THIS ITEM MAY CAUSE DISCOMFORT OR IRRITATION OF THE SKIN. THIS DEVICE HAS NOT BEEN CLINICALLY TESTED PLEASE REPORT ADVERSE REACTIONS TO THE MANUFACTURER OR TO [email protected].