Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70
FDA 510(k) K092012 · Primed Medical Products, Inc.
510(k) numberK092012
Submission
- Device name
- Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70
- Applicant
- Primed Medical Products, Inc.
Edmonton, Alberta, CA - Received
- July 6, 2009
- Decision date
- September 25, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | 09/11/2026SE |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…QSO · Traditional | 09/01/2026SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | 11/04/2025SE |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 10/07/2024SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | 08/26/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 05/24/2024SE |
| K213427 | PRIMED Pediatric FacemaskOXZ · Traditional | 11/22/2022SE |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC · Traditional | 11/04/2016SE |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksFXX · Special | 08/11/2008SE |
Questions and answers
When was Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70 cleared by the FDA?
Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70 (K092012) received a 510(k) decision of Substantially Equivalent on September 25, 2009, 81 days after the submission was received.
What is the product code of K092012?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.