Shanxi Hongjin Plastic Technology Co., Ltd.
Manufacturer and brand owner in Linfen, Shanxi, China. 5 device types, 2 products catalogued, 7 clearances.
Shanxi Hongjin Plastic Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Vinyl Patient Examination Glove and 3 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013565389 |
| FEI number | 3013565389 |
| DUNS | 544569383 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 山西鸿晋塑胶科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Linfen |
|---|---|
| Province | Shanxi |
| Address | Coal Bed Gas Industrial Zone, Qu’e Town |
| Postal code | 042300 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | 2022 | 29 |
| Medical Glove, Specialty | Class 1 | 2021 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2023 | 32 |
| Polymer Patient Examination Glove | Class 1 | 2020 | 83 |
| Vinyl Patient Examination Glove | Class 1 | 2017 | 72 |
Own-Brand Listings
Clearances
7 clearances name Shanxi Hongjin Plastic Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232550 | 2023-10-20 | LZA | Traditional | This company |
| K232353 | 2023-08-31 | LZA | Special | This company |
| K230779 | 2023-06-09 | LZA | Traditional | This company |
| K220229 | 2022-03-26 | LZA | Traditional | This company |
| K211604 | 2021-10-27 | LZA | Traditional | This company |
| K180381 | 2018-11-07 | LYZ | Traditional | This company |
| K180260 | 2018-06-12 | LYZ | Traditional | This company |
| K042378 | 2004-09-20 | LZA | Traditional | Shijiazhuang Tillotson Rubber Products Co., Ltd. |
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.