Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield— 510(k) K210147
Substantially EquivalentUnicoglobal, Inc.
FDA 510(k) clearance K210147 for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield, Substantially Equivalent on 2021-12-22. Applicant: Unicoglobal, Inc.. Device class: 2.
Clearance details
- Applicant
- Unicoglobal, 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
- Seongnam, KR
Recent devices under product code FXX
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- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Unicoglobal, Inc.
view allAdverse 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.