Regulatory / Design Considerations

FDA-approved provisional hand sanitizer documentation

3-ply surgical mask with water and oil droplet resistance, punch-out elastic straps, and flexible nose piece: FDA certification, Chinese certification

3-ply surgical mask with water and oil droplet resistance, punch out anti-tamper straps, and flexible nose piece: FDA Cross-Check

Level-II non-sterile isolation suit, Level-IIB sterile isolation suit: FDA certification

Level-II non-sterile isolation suit, Level-II non-sterile and Level-IIB sterile isolation suite: FDA Establishment Registration & Device Listing Cross-Check

Suppliers

Gina and Rissa Chen, Guangzhou, China — 3-ply surgical mask with water and oil droplet resistance, punch-out elastic straps (anti-tamper) and glasses fog-resistant/improved face seal flexible nose piece (FDA-certified)

Andy Didorosi, Detroit, Michigan — Hand sanitizer (WHO-approved)

Aaron Mitchell, Santa Clara, California — 3D-printed face shields with mouth coverage and high face surface area protection

Dr. Aaron Muraoka, DDS — 3D-printed face shields

Elena Zhao, San Jose, California — Valveless soft-shelled N95 masks