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              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