Orex Surgical Drapes
FDA 510(k) K944859 · Thantex Specialties, Inc.
510(k) numberK944859
Submission
- Device name
- Orex Surgical Drapes
- Applicant
- Thantex Specialties, Inc.
Herndon, VA, US - Received
- October 3, 1994
- Decision date
- February 28, 1995
- 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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| K970547 | Isolyser SDS Sharps ContainerFMI · Traditional | 07/18/1997SE |
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| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | 08/07/1995SE |
| K943626 | Isolyser Sharps Management System SMSFMI · Traditional | 06/16/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | 05/25/1995SE |
| K945223 | Orex Isolation GownFYC · Traditional | 04/25/1995SE |
| K944827 | Orex Surgeon's GownFYA · Traditional | 02/28/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | 12/20/1994SE |
| K940767 | Orex (12X12 X-Ray Detectable)GDY · Traditional | 12/19/1994SE |
Questions and answers
When was Orex Surgical Drapes cleared by the FDA?
Orex Surgical Drapes (K944859) received a 510(k) decision of Substantially Equivalent on February 28, 1995, 148 days after the submission was received.
What is the product code of K944859?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.