Xuzhou Full Sun Medical Products Ltd.
Registered establishment in Pizhou, Jiangsu, China. 3 device types, 8 clearances.
Xuzhou Full Sun Medical Products Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Vinyl Patient Examination Glove, Polymer Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2007.
3device types registered with the FDA
8510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006789222 |
| FEI number | 3006789222 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Pizhou |
|---|---|
| Province | Jiangsu |
| Address | Bihe Industry Area, Yitang Town |
| Postal code | 221316 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | 2020 | 182 | |
| Polymer Patient Examination Glove | Class 1 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | 2022 | 83 |
| Vinyl Patient Examination Glove | Class 1 | 2007 | 72 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210463 | 2022-01-23 | LZA | Traditional | This company |
| K111240 | 2011-07-14 | LYZ | Abbreviated | This company |
| K072377 | 2007-12-14 | LYZ | Abbreviated | This company |
| K071122 | 2007-12-12 | LYZ | Abbreviated | This company |
| K072314 | 2007-12-12 | LYZ | Abbreviated | This company |
| K072472 | 2007-10-25 | LYZ | Abbreviated | This company |
| K072401 | 2007-10-15 | LYZ | Abbreviated | This company |
| K071123 | 2007-07-30 | LYZ | Traditional | This company |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.