PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more— 510(k) K261811
Substantially EquivalentPRIMED Medical Products, Inc.
FDA 510(k) clearance K261811 for PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more, Substantially Equivalent on 2026-09-01. Applicant: PRIMED Medical Products, Inc.. Device class: 2.
Summary
PRIMED Medical Products, Inc. filed PRIMED Chemotherapy Drug Tested Gowns under product code QSO (Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs). The name lists two isolation gowns: PM4-99450 (Purple, AAMI Level 2) and PM4-99460 (Blue, AAMI Level 3).
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General, Plastic Surgery as the classification panel. The decision was Substantially Equivalent.
PRIMED filed from Edmonton, Canada. The decision came 92 calendar days after FDA received it (June 1 to September 1, 2026).
Clearance details
- Device name as filed
- 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
- Product code QSO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
Recent devices under product code QSO
view allMore clearances from PRIMED Medical Products, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.