Clearance Summary
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) received FDA 510(k) clearance under submission number K261811, sponsored by PRIMED Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-09-01.
- Submission: K261811
- Applicant / Sponsor: PRIMED Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2026-09-01
Classification & Regulation
This clearance is catalogued under FDA product code QSO and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.