PRIMED Surgical and Procedure Masks— 510(k) K252964
Substantially EquivalentPrimed Medical Products, Inc.
FDA 510(k) clearance K252964 for PRIMED Surgical and Procedure Masks, Substantially Equivalent on 2025-11-04. Applicant: Primed Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primed Medical Products, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
Recent devices under product code FXX
view all- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- K252534 — Surgical Face Mask (Ear mount)
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Primed Medical Products, Inc.
view all- K262007 — PRIMED AAMI Level 3 Open Back Gowns
- K261811 — PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.