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. "AAMI Level 3" refers to the ANSI/AAMI PB70 liquid barrier scale, where Level 3 is the moderate-risk tier.
Class II, 21 CFR 878.4040. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
The country code is CA, which here means Canada, not California: PRIMED Medical Products filed from Edmonton, Alberta. Review took 88 days (June 15 to September 11, 2026). Gown clearances are built around standardized barrier testing and tend to move fast.
Clearance details
- Applicant
- PRIMED Medical Products, Inc.
- Product code
- 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.