Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)— 510(k) K222266
Substantially EquivalentJingzhou Haixin Green Cross Medical Products Co., Ltd.
FDA 510(k) clearance K222266 for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80), Substantially Equivalent on 2022-09-26. Applicant: Jingzhou Haixin Green Cross Medical Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jingzhou Haixin Green Cross Medical 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
- Jingzhou, 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 Jingzhou Haixin Green Cross Medical 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.