Quali-Med's Operating Room Drapes
FDA 510(k) K862172 · Quali-Med, Inc.
510(k) numberK862172
Submission
- Device name
- Quali-Med's Operating Room Drapes
- Applicant
- Quali-Med, Inc.
Sugar Land, TX, US - Received
- June 9, 1986
- Decision date
- June 19, 1986
- 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 |
|---|---|---|
| K871408 | Blood Vessel Connector · Traditional | 04/27/1987SE |
| K862972 | Disposable Mirror · Traditional | 09/23/1986SE |
| K862472 | Quartz Rods Titanium RodsGEX · Traditional | 09/12/1986SE |
| K862241 | Standard Basin Kit Custom Basin KitFRG · Traditional | 08/01/1986SE |
| K862242 | Pap Smear KitHHT · Traditional | 06/26/1986SE |
| K861198 | Custom Procedure Kit (Various Sub-Titles) · Traditional | 05/16/1986SESD |
Questions and answers
When was Quali-Med's Operating Room Drapes cleared by the FDA?
Quali-Med's Operating Room Drapes (K862172) received a 510(k) decision of Substantially Equivalent on June 19, 1986, 10 days after the submission was received.
What is the product code of K862172?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.