Disposable O.R. Towel, Sterile
FDA 510(k) K915740 · American Threshold Industries, Inc.
510(k) numberK915740
Submission
- Device name
- Disposable O.R. Towel, Sterile
- Applicant
- American Threshold Industries, Inc.
Enka, NC, US - Received
- December 23, 1991
- Decision date
- June 22, 1992
- 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
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|---|---|---|---|
| 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 |
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| K971483 | Secure-Wrap (TM) Sterilization WrapFRG · Traditional | 06/24/1997SE |
| K953879 | Surgeon's CapFYF · Traditional | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | 01/05/1996SE |
| K952115 | Barrier Gown, Kool-Gard Backless GownFYC · Traditional | 09/25/1995SE |
| K952114 | Kool Gard Singles GownFYC · Traditional | 09/25/1995SE |
| K952116 | Cover GownFYC · Traditional | 09/05/1995SE |
| K934085 | Modification of Surgical Eyeshield MaskHOY · Traditional | 11/12/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | 08/17/1992SE |
| K912110 | Disposable O.R. TowelKKX · Traditional | 07/25/1991SE |
| K894383 | Disposable Shoe CoverFXP · Traditional | 09/12/1989SE |
Questions and answers
When was Disposable O.R. Towel, Sterile cleared by the FDA?
Disposable O.R. Towel, Sterile (K915740) received a 510(k) decision of Substantially Equivalent on June 22, 1992, 182 days after the submission was received.
What is the product code of K915740?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.