PRIMED AAMI Level 3 Open Back Gowns
FDA 510(k) K262007 · PRIMED Medical Products, Inc.
510(k) numberK262007
Submission
- Device name
- PRIMED AAMI Level 3 Open Back Gowns
- Applicant
- PRIMED Medical Products, Inc.
Edmonton, CA - Received
- June 15, 2026
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QPC – Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.
Other 510(k)s with product code QPC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns)QPC · Traditional | PolyConversions, Inc. | 08/11/2026SE |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns)QPC · Traditional | PolyConversions, Inc. | 12/16/2025SE |
| K242689 | AAMI Level 4 Protective; GownQPC · Traditional | Azac Group | 01/13/2025SE |
| K233526 | Medline Open-back Level 3 Protective GownQPC · Traditional | Medline Industries, LP | 03/05/2024SE |
| K230384 | PolyWear® Personal Protective Level 3 GownQPC · Traditional | PolyConversions, Inc. | 08/11/2023SE |
| K222128 | Protective Gown AAMI Level 4QPC · Traditional | Kenpax International Limited | 08/08/2023SE |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective GownQPC · Traditional | Dukal Corporation | 03/30/2022SE |
| K203821 | Donagamex Blue Performance Protective GownQPC · Traditional | Dong Nai Garment Corporation (Donagamex) | 12/17/2021SE |
| K210405 | ProTEC-USA EZDoff GownQPC · Traditional | Cadillac Products, Inc. | 12/15/2021SE |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC · Traditional | Cardinal Health200, LLC | 04/26/2019SE |
More from Cardinal Health200, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…QSO · Traditional | 09/01/2026SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | 11/04/2025SE |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 10/07/2024SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | 08/26/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 05/24/2024SE |
| K213427 | PRIMED Pediatric FacemaskOXZ · Traditional | 11/22/2022SE |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC · Traditional | 11/04/2016SE |
| K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…FXX · Special | 09/25/2009SE |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksFXX · Special | 08/11/2008SE |
Questions and answers
When was PRIMED AAMI Level 3 Open Back Gowns cleared by the FDA?
PRIMED AAMI Level 3 Open Back Gowns (K262007) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 88 days after the submission was received.
What is the product code of K262007?
The FDA product code is QPC – Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, a Class II (moderate risk) device regulated under 21 CFR 878.4040.