3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield— 510(k) K180874
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K180874 for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield, Substantially Equivalent on 2018-07-31. Applicant: 3M Healthcare. Device class: 2.
Clearance details
- Applicant
- 3M Healthcare
- 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
- St. Paul, MN, US
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 3M Healthcare
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- K191355 — 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
- K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
- K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
- K153571 — Cavilon Advanced High Endurance Skin Protectant
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.