Amseal Surgical Face Mask
FDA 510(k) K964358 · American Seal Co.
510(k) numberK964358
Submission
- Device name
- Amseal Surgical Face Mask
- Applicant
- American Seal Co.
Hayward, CA, US - Received
- November 1, 1996
- Decision date
- February 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
More from Winner Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | 09/09/1997SE |
| K972187 | Bouffant CapKKX · Traditional | 09/09/1997SE |
| K970814 | Non-Sterile Isolation GownFYC · Traditional | 05/27/1997SE |
| K892557 | Maytex Non-Sterile Latex Exam GloveLYY · Traditional | 05/31/1989SE |
| K892553 | Maytex Patient Examination GlovesLYY · Traditional | 05/25/1989SE |
Questions and answers
When was Amseal Surgical Face Mask cleared by the FDA?
Amseal Surgical Face Mask (K964358) received a 510(k) decision of Substantially Equivalent on February 14, 1997, 105 days after the submission was received.
What is the product code of K964358?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.