Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)— 510(k) K211750
Substantially EquivalentNational Bridge Industrial (S.Z.) Co., Ltd.
FDA 510(k) clearance K211750 for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile), Substantially Equivalent on 2021-12-20. Applicant: National Bridge Industrial (S.Z.) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- National Bridge Industrial (S.Z.) 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
- Shenzhen, 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.