Description

The following refers to: 3DPX-013887 The FDA has authorized production of protective face shields outside of the normal clearance pathway during the COVID-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff." This face shield has undergone review in a clinical setting and is recommended when fabricated as instructed. Deriviation of DtM face shield that is moldable in a straght pull mold. Forehead Visor Material: Bayblend FR110 PC/ABS blend. Elastic Strap Material: Polyester PLEASE SEE DOCUMENTATION TAB FOR INSTRUCTIONS FOR USE AND OTHER DOCUMENTATION