PRIMED AAMI Level 3 Open Back Gowns— 510(k) K262007
Substantially EquivalentPRIMED Medical Products, Inc.
FDA 510(k) clearance K262007 for PRIMED AAMI Level 3 Open Back Gowns, Substantially Equivalent on 2026-09-11. Applicant: PRIMED Medical Products, Inc.. Device class: 2.
Summary
PRIMED AAMI Level 3 Open Back Gowns fall under QPC: non-sterile, non-isolation gowns meant to provide moderate or high barrier protection. The record doesn't define "AAMI Level 3."
Class II, 21 CFR 878.4040, filed as a Traditional 510(k). The record lists General and Plastic Surgery as the advisory panel and General Hospital as the review panel.
The country code is CA, which here means Canada, not California: PRIMED Medical Products filed from Edmonton. Review took 88 days (June 15 to September 11, 2026).
Clearance details
- Applicant
- PRIMED Medical Products, Inc.
- Product code
- Product code QPC
- 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 QPC
view allMore clearances from PRIMED Medical Products, Inc.
view all- K261811 — PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more
- K252964 — PRIMED Surgical and Procedure Masks
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Data sourced from openFDA. This site is unofficial and independent of the FDA.