510(k) clearance
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)
- 510(k) number
- K261811
- Applicant
- PRIMED Medical Products, Inc.
- Decision date
- Sep 1, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QSO
- Device type
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Edmonton, CA