3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
FDA 510(k) K222578 · 3M Company
510(k) numberK222578
Submission
- Device name
- 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
- Applicant
- 3M Company
St. Paul, MN, US - Received
- August 25, 2022
- Decision date
- May 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Other 510(k)s with product code KKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
| K140250 | 3M Steri-Drape CHG Antimicrobial Incise DrapeKKX · Traditional | 3M Healthcare | 07/25/2014SE |
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Questions and answers
When was 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) cleared by the FDA?
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578) received a 510(k) decision of Substantially Equivalent on May 18, 2023, 266 days after the submission was received.
What is the product code of K222578?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.