Surgifresh Sub-Micron Mask No. 901008-000
FDA 510(k) K893417 · Texas Medical Products, Inc.
510(k) numberK893417
Submission
- Device name
- Surgifresh Sub-Micron Mask No. 901008-000
- Applicant
- Texas Medical Products, Inc.
The Woodlands, TX, US - Received
- May 2, 1989
- Decision date
- June 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
|---|---|---|
| K870932 | Surgifresh Surgical Smoke Removal · Traditional | 03/31/1987SE |
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| K830634 | Cardiotomy FilterJOD · Traditional | 06/30/1983SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
| K802543 | Ridgid Vena Cava CannulaeDWF · Traditional | 01/16/1981SE |
Questions and answers
When was Surgifresh Sub-Micron Mask No. 901008-000 cleared by the FDA?
Surgifresh Sub-Micron Mask No. 901008-000 (K893417) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 51 days after the submission was received.
What is the product code of K893417?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.