Plus Surgical Drapes (EO Sterilized), PMDB-XXX
FDA 510(k) K133080 · Foshan Nanhai Plus Medical Co, Ltd.
510(k) numberK133080
Submission
- Device name
- Plus Surgical Drapes (EO Sterilized), PMDB-XXX
- Applicant
- Foshan Nanhai Plus Medical Co, Ltd.
Dover, DE, US - Received
- September 30, 2013
- Decision date
- June 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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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| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)FYA · Traditional | 11/14/2022SE |
| K213177 | Plus Medical Cover GownFYA · Traditional | 05/11/2022SE |
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| K212698 | Plus Medical Isolation Gown Level 3FYC · Traditional | 03/02/2022SE |
| K212610 | Surgical Face MaskFXX · Traditional | 01/26/2022SE |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)FYA · Traditional | 07/22/2021SE |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXXFYA · Traditional | 06/24/2015SE |
Questions and answers
When was Plus Surgical Drapes (EO Sterilized), PMDB-XXX cleared by the FDA?
Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080) received a 510(k) decision of Substantially Equivalent on June 24, 2015, 632 days after the submission was received.
What is the product code of K133080?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.