Procedure mask/Surgical mask/Face mask
FDA 510(k) K250082 · Winner Medical Co., Ltd.
510(k) numberK250082
Submission
- Device name
- Procedure mask/Surgical mask/Face mask
- Applicant
- Winner Medical Co., Ltd.
Shenzhen, CN - Received
- January 13, 2025
- Decision date
- June 18, 2025
- 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 |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…FXX · Abbreviated | Owens & Minor (O&M) Halyard, Inc. | 05/30/2025SE |
More from Owens & Minor (O&M) Halyard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252001 | Collagen Wound DressingKGN · Traditional | 10/10/2025SE |
| K231057 | Antibacterial Gel Wound DressingFRO · Traditional | 12/01/2023SE |
| K231564 | Skin and Wound CleanserFRO · Traditional | 11/10/2023SE |
| K231152 | Collagen Wound DressingKGN · Traditional | 10/12/2023SE |
| K221311 | Antibacterial BandageFRO · Traditional | 06/21/2023SE |
| K223232 | Procedure mask/Surgical mask/Face maskFXX · Traditional | 03/06/2023SE |
| K221532 | PHMB Wound DressingFRO · Traditional | 01/30/2023SE |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…FRO · Special | 01/17/2023SE |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…FRO · Special | 01/13/2023SE |
| K221720 | Extra Silver Gelling Fiber DressingFRO · Traditional | 12/21/2022SE |
Questions and answers
When was Procedure mask/Surgical mask/Face mask cleared by the FDA?
Procedure mask/Surgical mask/Face mask (K250082) received a 510(k) decision of Substantially Equivalent on June 18, 2025, 156 days after the submission was received.
What is the product code of K250082?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.