Surgical Mask-Model Number: Ear Loop, Flat-Pleated— 510(k) K201852
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K201852 for Surgical Mask-Model Number: Ear Loop, Flat-Pleated, Substantially Equivalent on 2021-03-02. Applicant: Huizhou Foryou Medical Devices Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Huizhou Foryou Medical Devices 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
- Abbreviated
- Location
- Huizhou, 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 Huizhou Foryou Medical Devices Co., Ltd.
view all- K254256 — LUOFUCON® Wound Matrix
- K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- K240809 — LUOFUCON® Silver Collagen Dressing
- K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
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.