Hongyu Disposable Surgical Drapes
FDA 510(k) K141324 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
510(k) numberK141324
Submission
- Device name
- Hongyu Disposable Surgical Drapes
- Applicant
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Shanghai, CN - Received
- May 20, 2014
- Decision date
- April 14, 2015
- 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 |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| 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 |
| 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 |
More from 3M Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K214088 | Disposable Surgical GownFYA · Traditional | 04/12/2022SE |
| K220133 | Sterilization WrapsFRG · Traditional | 03/10/2022SE |
| K213029 | Nitrile Examination Gloves (Powder free, Blue)LZA · Traditional | 12/14/2021SE |
| K212807 | Surgical MasksFXX · Traditional | 12/03/2021SE |
| K120192 | Disposable Surgical GownsFYA · Traditional | 10/16/2012SE |
Questions and answers
When was Hongyu Disposable Surgical Drapes cleared by the FDA?
Hongyu Disposable Surgical Drapes (K141324) received a 510(k) decision of Substantially Equivalent on April 14, 2015, 329 days after the submission was received.
What is the product code of K141324?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.