Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))— 510(k) K203418
Substantially EquivalentNingbo Ouhan Medical Device Co., Ltd.
FDA 510(k) clearance K203418 for Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)), Substantially Equivalent on 2021-09-17. Applicant: Ningbo Ouhan Medical Device Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ningbo Ouhan Medical Device Co., Ltd.
- 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
- Yuyao City, CN
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
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.