Cardinal HealthTM Poly-Coated Open-Back Protective Gown
FDA 510(k) K182830 · Cardinal Health200, LLC
510(k) numberK182830
Submission
- Device name
- Cardinal HealthTM Poly-Coated Open-Back Protective Gown
- Applicant
- Cardinal Health200, LLC
Waukegan, IL, US - Received
- October 5, 2018
- Decision date
- April 26, 2019
- 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.
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|---|---|---|---|
| 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 |
| 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 |
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| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO · Traditional | 09/26/2021SE |
| K211390 | Nitrile Blue Powder-free Examination GloveLZA · Traditional | 08/28/2021SE |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR…FYA · Traditional | 07/29/2020SE |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional | 03/20/2020SE |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam StripFXX · Traditional | 12/02/2019SE |
| K181174 | Cardinal Health Sterilization WrapFRG · Traditional | 12/11/2018SE |
Questions and answers
When was Cardinal HealthTM Poly-Coated Open-Back Protective Gown cleared by the FDA?
Cardinal HealthTM Poly-Coated Open-Back Protective Gown (K182830) received a 510(k) decision of Substantially Equivalent on April 26, 2019, 203 days after the submission was received.
What is the product code of K182830?
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.