Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask— 510(k) K211832
Substantially EquivalentZhejiang Lanhine Medical Products, Ltd.
FDA 510(k) clearance K211832 for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask, Substantially Equivalent on 2021-09-08. Applicant: Zhejiang Lanhine Medical Products, Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Lanhine Medical Products, 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
- Cixi, 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
More clearances from Zhejiang Lanhine Medical Products, Ltd.
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.