3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask— 510(k) K191355
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K191355 for 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask, Substantially Equivalent on 2019-09-11. 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
view all- K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- 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.