FAQs

How are TracerShields manufactured?

Our phased approach is tooled for simplicity, speed and scale. Our PETG sheets are die-cut, the plastic components are injection molded and are then packaged together with the other components in a clean facility.

How are TracerShield kits packaged?

Each kit is individually packaged in a poly bag, which are then packaged 50 kits to a case.

Do TracerShields meet the FDA Guidance protocols?

To help increase availability of Personal Protective Equipment (PPE), the FDA has issued an Emergency Usage Authorization (EUA) temporarily waiving certification requirements for some kinds of devices during the public health emergency, specifically including face shields intended for a medical purpose. The FDA defines devices as intended for a medical purpose when they are used in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. The below PDF is the revised version of the FDA’s “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease Public Health Emergency.” Section 5-D on p.6 details the FDA recommendation on Face Shields Intended for a Medical Purpose. In summary it reads, “To help foster the availability of equipment that might offer some benefit to health care providers and the general public during the COVID-19 outbreak, for the duration of the public health emergency, FDA does not intend to object to the distribution and use of face shields that are intended for a medical purpose (whether used by medical personnel or the general public). The FDA currently believes such devices would not create such an undue risk where:

  • The product includes labeling that accurately describes the product as a face shield and includes a list of the body contacting materials (which does not include any drugs, or biologics);
  • The face shield does not contain any materials that will cause flammability, or the product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, or for radiation protection.

Click here to see that TracerShield meets the “Enforcement Policy for Face Masks & Respirators Durng the Coronavirus Disease (COVID-19) Public Health Emergency”.

Who is Tracer?

Tracer Imaging is the classic story of New York spirit, innovation and grit. The company was founded in 2004 in the suburbs of New York City. While our roots are in lenticular printing, we’ve diversified and grown into the retail photo space. The photo and décor products we’ve invented are sold in over 7,000 retail locations around the country and can be ordered from anywhere in the world. Some of our clients include Walgreens, Johnson & Johnson, CrackerBarrel, ChapStick, MillerCoors, smashbox, and NASA.

Click this link or click our logo right next to this paragraph to find out more about Tracer.