FXX — Mask, Surgical Class II
FDA product code FXX covers "Mask, Surgical", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FXX
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251967 | o and m halyard | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT | March 18, 2026 |
| K252534 | zhejiang hangkang medical equipment co | Surgical Face Mask (Ear mount) | March 3, 2026 |
| K253398 | efofex | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | February 19, 2026 |
| K252830 | beatles medical supplies (xiantao) co | Disposable Surgical Face Mask (3P00B, C2900) | January 12, 2026 |
| K252650 | makrite industries | Disposable Medical Face Mask | January 5, 2026 |
| K243342 | kp trading co | KP Protective Face Mask | December 22, 2025 |
| K252941 | o and m halyard | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | December 11, 2025 |
| K252964 | primed medical products | PRIMED Surgical and Procedure Masks | November 4, 2025 |
| K251902 | vitacore industries | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S | September 17, 2025 |
| K250082 | winner medical co | Procedure mask/Surgical mask/Face mask | June 18, 2025 |
| K243010 | owens and minor (o and m) halyard | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); | May 30, 2025 |
| K242502 | supermax healthcare canada supermax medical | Aurelia Surgical Mask ASTM Level-3 (2130) | November 12, 2024 |
| K240916 | xiantao daoqi plastic co | Surgical Face Mask (Tie on/ Ear loops) | October 18, 2024 |
| K240286 | primed medical products | PRIMED Surgical Masks and PRIMED Procedure Masks | August 26, 2024 |
| K233723 | guangdong kingfa sci. and tech.co | Medical surgical mask | July 29, 2024 |
| K232824 | owens and minor (o and m) halyard | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloop | July 2, 2024 |
| K232777 | owens and minor (o and m) halyard | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavend | July 1, 2024 |
| K232807 | owens and minor (o and m) halyard | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); | June 21, 2024 |
| K232812 | owens and minor (o and m) halyard | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical | June 14, 2024 |
| K232806 | owens and minor (o and m) halyard | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops | June 7, 2024 |