3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
FDA 510(k) K191355 · 3M Healthcare
510(k) numberK191355
Submission
- Device name
- 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
- Applicant
- 3M Healthcare
St. Paul, MN, US - Received
- May 21, 2019
- Decision date
- September 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face ShieldFXX · Traditional | 07/31/2018SE |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemNJM · Traditional | 03/16/2018SE |
| K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804SMSH · Traditional | 08/10/2017SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 08/23/2016SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 08/18/2014SE |
| K140250 | 3M Steri-Drape CHG Antimicrobial Incise DrapeKKX · Traditional | 07/25/2014SE |
| K974445 | 3M Red Dot Resting EKG Electrode, Catalog 2360DRX · Traditional | 07/26/1998SE |
| K980732 | 3M Cdi Quick-Cells with Heparin TreatmentDRY · Traditional | 05/15/1998SE |
| K974553 | 3M Universal Electrosurgical Pad, Split (9160) 3M Universal Electrosurgical Pad (9130)GEI · Traditional | 02/03/1998SE |
Questions and answers
When was 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask cleared by the FDA?
3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask (K191355) received a 510(k) decision of Substantially Equivalent on September 11, 2019, 113 days after the submission was received.
What is the product code of K191355?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.