Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On— 510(k) K201732
Substantially EquivalentDukal Corporation
FDA 510(k) clearance K201732 for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On, Substantially Equivalent on 2021-02-16. Applicant: Dukal Corporation. Device class: 2.
Clearance details
- Applicant
- Dukal Corporation
- 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
- Ronkonkoma, NY, 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 Dukal Corporation
view all- K212464 — Dukal Corporation AAMI Level 4 Open-Back Protective Gown
- K210321 — Dukal Corporation Level 1 Pediatric Face Mask
- K203237 — Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
- K201421 — Dukal Corporation Level 2 Surgical Mask with Ear Loops +2 more
- K113689 — DUKAL LUBRICATING JELLY
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.