US device clearances
8 510(k) clearances and PMA approvals since 2015
- Standard Surgical Gown (Aami Level 2); Reinforced Surgical Gown (Aami Level 2) K222480 · 14 Nov 2022
- Plus Medical Cover Gown K213177 · 11 May 2022
- Plus Medical Chemotherapy Gown K211036 · 4 May 2022
- Plus Medical Isolation Gown Level 3 K212698 · 2 Mar 2022
- Surgical Face Mask K212610 · 26 Jan 2022
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.