Disposable medical surgical mask— 510(k) K212097
Substantially EquivalentHebei Titans Hongsen Medical Technology Co., Ltd.
FDA 510(k) clearance K212097 for Disposable medical surgical mask, Substantially Equivalent on 2021-08-18. Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hebei Titans Hongsen Medical Technology 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
- Xingtai, 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 Hebei Titans Hongsen Medical Technology Co., Ltd.
view all- K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL) +2 more
- K223895 — Disposable Medical Nitrile Examination Gloves
- K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
- K211229 — Vinyl compound examination gloves
- K182043 — Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
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.