FXX
- Product code
- FXX
- Device name
- Mask, Surgical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 30
- Summaries archived here
- 28 (direct download)
- 510(k) clearances (all years, FDA)
- 607 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (30)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251967 | 2026-03-18 | O&M Halyard, Inc. | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with… | |
| K252534 | 2026-03-03 | Zhejiang Hangkang Medical Equipment Co… | Surgical Face Mask (Ear mount) | — |
| K253398 | 2026-02-19 | Efofex, Inc. | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK… | |
| K252830 | 2026-01-12 | Beatles Medical Supplies (Xiantao) Co.… | Disposable Surgical Face Mask (3P00B, C2900) | |
| K252650 | 2026-01-05 | Makrite Industries, Inc. | Disposable Medical Face Mask | |
| K243342 | 2025-12-22 | Kp Trading Co., Ltd. | KP Protective Face Mask | |
| K252941 | 2025-12-11 | O&M Halyard, Inc. | HALYARD* Adult Face Mask with SO SOFT* Lining and SO… | |
| K252964 | 2025-11-04 | Primed Medical Products, Inc. | PRIMED Surgical and Procedure Masks | |
| K251902 | 2025-09-17 | Vitacore Industries, Inc. | Vitaform Procedural Mask - Blue (Vitaform Blue); Vit… | |
| K250082 | 2025-06-18 | Winner Medical Co., Ltd. | Procedure mask/Surgical mask/Face mask | |
| K243010 | 2025-05-30 | Owens & Minor (O&M) Halyard, Inc. | Fluidshield * 3 Fog-Free Surgical Mask with Wraparou… | |
| K242502 | 2024-11-12 | Supermax Healthcare Canada Supermax … | Aurelia Surgical Mask ASTM Level-3 (2130) | FDA |
| K240916 | 2024-10-18 | Xiantao Daoqi Plastic Co., Ltd. | Surgical Face Mask (Tie on/ Ear loops) | |
| K240286 | 2024-08-26 | Primed Medical Products, Inc. | PRIMED Surgical Masks and PRIMED Procedure Masks | |
| K233723 | 2024-07-29 | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Medical surgical mask | |
| K232824 | 2024-07-02 | Owens & Minor (O&M) Halyard, Inc. | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT*… | |
| K232777 | 2024-07-01 | Owens & Minor (O&M) Halyard, Inc. | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining a… | |
| K232807 | 2024-06-21 | Owens & Minor (O&M) Halyard, Inc. | Fluidshield* 1 Procedure Mask with SO SOFT* Lining a… | |
| K232812 | 2024-06-14 | Owens & Minor (O&M) Halyard, Inc. | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluid… | |
| K232806 | 2024-06-07 | Owens & Minor (O&M) Halyard, Inc. | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft … | |
| K232968 | 2024-06-06 | Golden Grande Corp. | Grande Medical Masks, Model SF-600 | |
| K232820 | 2024-06-04 | Owens & Minor (O&M) Halyard, Inc. | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with … | |
| K240258 | 2024-04-18 | Makrite Industries, Inc. | Disposable Medical Face Mask (M643BE) | |
| K232112 | 2024-04-02 | R&G Seguridad E Higiene Industrial S.A… | R&G Surgical Mask | |
| K231719 | 2024-03-19 | Azur Medical Company, Inc. | Medical Surgical Mask | |
| K232894 | 2024-01-08 | Owens & Minor (O&M) Halyard, Inc. | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded … | |
| K232797 | 2023-12-11 | Shenzhen Hygenix Industrial Co., Ltd. | Hygenix | |
| K231005 | 2023-12-05 | Supermax Healthcare Canada-Supermax Me… | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical… | |
| K231155 | 2023-11-07 | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Biodegradable Medical surgical mask | |
| K232359 | 2023-10-02 | Kingstar Medical (Xianning) Co., Ltd. | Surgical face mask |
Official FDA classification page: FXX
Classification and pathway per current FDA publications. Data from openFDA (CC0).