MEDICAL FACE SHIELDS
STAR MOUNTAIN MEDICAL
Is a loose-fitting, single use disposable device that creates a physical barrier between the
face of the wearer and potential contaminants in the immediate environment, either sterile or nonsterile.
When worn properly, the Star Mountain Medical Technologies Face Shield is meant to help provide facial area and related mucous membrane (eyes, nose, lips) protection against large-particle droplets, splashes, and sprays of blood, body fluids, excretions, secretions, and other potentially infectious materials in the environment where biological hazards are expected, keeping them from reaching to face.
- Provides protection against potential contaminants when used with other personal protective equipment (PPE).
- Face Shield is available in full-face length with outer edges of the face shield reaching at least to the point of the ear, including chin and forehead protection.
- Face Shield is lightweight, and comfortable to wear.
- Anti-fog coating on both sides.
- A non-irritating foam for sensitive skin and comfortable wear.
- Latex-free attached elastic headband gives the Face Shield strength and reliability.
|Product Code||Product Description||Packing Per Box||Height Dimension||Width Dimension|
|11795089||Face Shield||100 units||9’’||13’’|
Face Shield dimensions: 9” (H) x 13” (W).
Each Face Shield goes into an open end 13 x 14” 1 mil Polybag.
Packaged in 22.5” x 17.5” x 13.5” shipping box (100 units / shipping box).
|Classification Regulation||Device Type||Product Code|
21 CFR 878.4040
|Pediatric/ Child Facemask||OXZ|
|Accessory, Surgical Apparel (Face Shield)⁸||LYU|
|Surgical mask with antimicrobial/ Antiviral Agent||OUK|
|N95 Respirator with antimicrobial/ Antiviral Agent||ONT|
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-10) Public Health
Emergency (Revised) / Guidance for Industry and Food and Drug Administration Staff /
https://www.fda.gov/media/136449/download/ Table 1 – Page 3