Data / Medical devices / China / Guangdong Golden Leaves Technology Development Co., Ltd.
Guangdong Golden Leaves Technology Development Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance
Guangdong Golden Leaves Technology Development Co., Ltd. is registered with the FDA (registration 3016635391) in Dongguan Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016635391
- Address
- 5 / F, building 2, No. 8, qiaolonghe East Road, Tangxia Town, Dongguan Guangdong, China, 523730
- Owner or operator
- Guangdong golden leaves Technology Development Co., Ltd. (10062979)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 14, 2020
- Registered through
- 2026
- Brand names listed
- 6661, Particle Filtering Half Mask FFP3; 6661, Folding Protective Mask KN95 6662, Particle Filtering Half Mask FFP3, 6662, Folding Protective Mask KN95 8801, Cup Shape Protective Mask FFP2, 8801V, Cup Shape Protective Mask FFP2; 8860, Kids Foldable Protective Mask (Non-Medical), 8860, KN95 Disposable Protective Mask; 8861, Folding Protective Mask KN95, 8861, Particle Filtering Half Mask FFP2; 8861H, Folding Protective Mask KN95; 8861H, Particle Filtering Half Mask FFP2, 8861V, Folding Protective Mask KN95 With Valve; 8861V, Particle Filtering Half Mask FFP2 With Valve, 8862, Fish Shape Protective Mask KN95; 8862, Particle Filtering Half Mask FFP2; 8865, Folding Protective Mask KN95, 8865, Particle Filtering Half Mask FFP2; 8868, Particle Filtering Half Mask FFP2; 9901,Cup Shape Protective Mask FFP2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2022 | K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) | FXX | Substantially Equivalent | Guangdong Golden Leaves Technology Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Radiographic Protective Glove
Updated November 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.