3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
FDA 510(k) clearance K222578 · decided 2023-05-18
Clearance details
- K-number
- K222578
- Device name
- 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 2022-08-25
- Decision date
- 2023-05-18
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645) | Avery Dennison Medical , Ltd. | 2023-10-25 |
| BeneHold Surgical Incise Drape with CHG antimicrobial (K202208) | Avery Dennison Belgie Bvba | 2021-07-30 |
| ControlRad Sterile Cover (K200238) | Controlrad, Inc. | 2020-04-26 |
| MediClear PreOp (K163556) | Covalontechnologies, Inc. | 2017-09-14 |
| Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080) | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| HONGYU DISPOSABLE SURGICAL DRAPES (K141324) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 |
| SURGICAL DRAPE (K140195) | Griffith-Lucas, LLC | 2014-09-10 |
| 3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330) | 3M Healthcare | 2014-08-18 |
| WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438) | Whitney Medical Solutions | 2014-08-14 |
| 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250) | 3M Healthcare | 2014-07-25 |
| SURGISLEEVE WOUND PROTECTOR (K140064) | Covidien | 2014-03-12 |
| AVD RIGHT RADIAL DRAPE (K131571) | Advanced Vascular Dynamics | 2014-01-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |