Caretex or Towel
FDA 510(k) K884112 · James River Corp.
510(k) numberK884112
Submission
- Device name
- Caretex or Towel
- Applicant
- James River Corp.
Neenah, WI, US - Received
- September 29, 1988
- Decision date
- October 13, 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 |
|---|---|---|
| K894505 | Cotolin Drain Sponge and Dressing SpongeEFQ · Traditional | 09/15/1989SE |
| K894147 | Visulin Transparent Adhesive DressingKGX · Traditional | 08/09/1989SN |
| K894034 | Modified Labeling of Surgical GlovesKGO · Traditional | 07/14/1989SE |
| K893939 | Isolation MasksFXX · Traditional | 07/14/1989SE |
| K892580 | Caretouch Examination GlovesLYY · Traditional | 07/14/1989SE |
| K890459 | James River Biogel Powderless Surgical GlovesKGO · Traditional | 04/20/1989SE |
| K883802 | Caretex Central Supply WrapFRG · Traditional | 10/21/1988SE |
| K883657 | Skid Resistant, Long Lasting Shoe CoversFXP · Traditional | 09/15/1988SE |
| K880481 | Caretex Surgeon's CapsFYF · Traditional | 02/24/1988SE |
| K880431 | Caretex Surgeon's HoodsFXY · Traditional | 02/24/1988SE |
Questions and answers
When was Caretex or Towel cleared by the FDA?
Caretex or Towel (K884112) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 14 days after the submission was received.
What is the product code of K884112?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.