Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
FDA 510(k) K230569 · Cardinalhealth
510(k) numberK230569
Submission
- Device name
- Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
- Applicant
- Cardinalhealth
Waukegan, IL, US - Received
- March 1, 2023
- Decision date
- July 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FXX – Mask, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional | O&M Halyard, Inc. | 03/18/2026SE |
| K252534 | Surgical Face Mask (Ear mount)FXX · Traditional | Zhejiang Hangkang Medical Equipment Co., Ltd. | 03/03/2026SE |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special | Efofex, Inc. | 02/19/2026SE |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional | Beatles Medical Supplies (Xiantao) Co., Ltd. | 01/12/2026SE |
| K252650 | Disposable Medical Face MaskFXX · Traditional | Makrite Industries, Inc. | 01/05/2026SE |
| K243342 | KP Protective Face MaskFXX · Traditional | Kp Trading Co., Ltd. | 12/22/2025SE |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional | O&M Halyard, Inc. | 12/11/2025SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 11/04/2025SE |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional | Vitacore Industries, Inc. | 09/17/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 06/18/2025SE |
More from Winner Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs… · Traditional | 09/02/2026SE |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended CuffLZC · Traditional | 01/14/2026SE |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe…FMF · Traditional | 08/22/2025SE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | 12/19/2024SE |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 05/19/2022SE |
| K202217 | Kendall NPWT Incision Management DeviceOMP · Traditional | 06/04/2021SE |
| K191101 | Kendall NPWT Incision Management Dressing KitOMP · Traditional | 07/31/2020SE |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 11/07/2019SE |
| K171499 | Occlusion Detection Dressing KitOMP · Traditional | 09/22/2017SE |
| K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetOMP · Traditional | 01/19/2017SE |
Questions and answers
When was Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) cleared by the FDA?
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) (K230569) received a 510(k) decision of Substantially Equivalent on July 3, 2023, 124 days after the submission was received.
What is the product code of K230569?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.