FXX
- 产品代码
- FXX
- 器械名称
- Mask, Surgical
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4040
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 30 件
- 其中 Summary 已存档
- 28 份，可直接下载
- FDA 历史累计 510(k)
- 607 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（30 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页： FXX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。