Dukal Corporation AAMI Level 4 Open-Back Protective Gown
FDA 510(k) K212464 · Dukal Corporation
510(k) numberK212464
Submission
- Device name
- Dukal Corporation AAMI Level 4 Open-Back Protective Gown
- Applicant
- Dukal Corporation
Ronkonkoma, NY, US - Received
- August 6, 2021
- Decision date
- March 30, 2022
- 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 |
|---|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | PRIMED Medical Products, Inc. | 09/11/2026SE |
| 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 |
| 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 |
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| K210321 | Dukal Corporation Level 1 Pediatric Face MaskOXZ · Traditional | 03/29/2022SE |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…FYA · Traditional | 03/18/2022SE |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…FXX · Traditional | 02/16/2021SE |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…FXX · Traditional | 02/05/2021SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | 05/04/2012SE |
| K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeKKX · Traditional | 03/06/2009SE |
| K070692 | Dukal N95PARTICULATE Respirator/Surgical Face MaskMSH · Traditional | 05/30/2007SE |
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Questions and answers
When was Dukal Corporation AAMI Level 4 Open-Back Protective Gown cleared by the FDA?
Dukal Corporation AAMI Level 4 Open-Back Protective Gown (K212464) received a 510(k) decision of Substantially Equivalent on March 30, 2022, 236 days after the submission was received.
What is the product code of K212464?
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.