Surgical Face Mask (HNFM0304)— 510(k) K221222
Substantially EquivalentShanghai Hua EN Industrial Co, Ltd.
FDA 510(k) clearance K221222 for Surgical Face Mask (HNFM0304), Substantially Equivalent on 2022-06-06. Applicant: Shanghai Hua EN Industrial Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai Hua EN Industrial 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
- Shanghai, CN
Recent devices under product code FXX
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- K252650 — Disposable Medical Face Mask
More clearances from Shanghai Hua EN Industrial 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.