Data / Medical devices / China / Zhejiang Lanhine Medical Products Ltd.
Zhejiang Lanhine Medical Products Ltd.: FDA-registered device maker in Cixi City Zhejiang, China, 2 510(k) clearances
Zhejiang Lanhine Medical Products Ltd. is registered with the FDA (registration 3016654890) in Cixi City Zhejiang, China. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016654890
- Address
- No.99, 2nd Songpu Road, Binhai Economic Development Zone, Cixi City Zhejiang, China, 315300
- Owner or operator
- Zhejiang Lanhine Medical Products Ltd. (10063119)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 17, 2020
- Registered through
- 2026
- Brand names listed
- 3 poly face mask, surgical mask, face mask, Type IIR mask, ASTM II mask, Cotton Swab, Disposible Face Mask, ASTM I MASK, ASTM III Mask, Eye Shield, FLUID RESISTANT SURGICAL MASK ; FLUID RESISTANT PROCEDURE MASK, Face Shield, Fever Reducing Gel, Cooling Gel, Antipyretic Gel, Fever Patch, Cooling Patch, Gel, Fever Reducing Gel, Cooling Gel, Antipyretic Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gelatin | IEX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 23, 2021 | K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) | FXX | Substantially Equivalent | Zhejiang Lanhine Medical Products, Ltd. | accessdata.fda.gov |
| September 8, 2021 | K211832 | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask | FXX | Substantially Equivalent | Zhejiang Lanhine Medical Products, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Adhesive Backed Thermal Skin Patches
- All makers of Accessory, Surgical Apparel
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Respirator, Surgical
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Mask, Surgical
Updated September 23, 2021. 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.