Device Listing 2043827013
Listing Summary#
- Listing key
- 2043827013
- Premarket submission
- K261811
- Device
- PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
- Applicant
- PRIMED Medical Products, Inc.
- Product code
- QSO
- Decision date
- 2026-09-01