Disposable Medical Face Mask (ear loop)— 510(k) K221196
Substantially EquivalentXiantao Topmed Nonwoven Protective Products Co., Ltd.
FDA 510(k) clearance K221196 for Disposable Medical Face Mask (ear loop), Substantially Equivalent on 2022-07-22. Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xiantao Topmed Nonwoven Protective Products 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
- Xiantao, 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 Xiantao Topmed Nonwoven Protective Products Co., 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.