Operating Room Towels -Sterile & Non-Sterile
FDA 510(k) K881396 · A Plus International, Inc.
510(k) numberK881396
Submission
- Device name
- Operating Room Towels -Sterile & Non-Sterile
- Applicant
- A Plus International, Inc.
La Puente, CA, US - Received
- April 4, 1988
- Decision date
- April 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K213001 | Procedure Mask, Surgical MaskFXX · Traditional | 05/11/2022SE |
| K102861 | Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with Pe Laminated…KKX · Traditional | 01/13/2011SE |
| K093169 | Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown…FYA · Traditional | 11/12/2009SE |
| K031353 | Solution Face MasksFXX · Traditional | 06/19/2003SE |
| K882284 | Surgeons CapFYF · Traditional | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | 06/23/1988SE |
| K882282 | Suit, SurgicalFXO · Traditional | 06/23/1988SE |
| K882281 | Gown, Isolation, Surgical (Fyc)FYC · Traditional | 06/23/1988SE |
| K882280 | Cover, Shoe Operating RoomFXP · Traditional | 06/23/1988SE |
| K881395 | Gauze and Lap Sponges -Sterile & Non-SterileEFQ · Traditional | 04/28/1988SE |
Questions and answers
When was Operating Room Towels -Sterile & Non-Sterile cleared by the FDA?
Operating Room Towels -Sterile & Non-Sterile (K881396) received a 510(k) decision of Substantially Equivalent on April 29, 1988, 25 days after the submission was received.
What is the product code of K881396?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.