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

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