Xinwei (Shandong) Plastic AND Rubber Products Co Ltd.
Registered establishment in Zibo, Shandong, China. 4 device types, 1 clearance.
Xinwei (Shandong) Plastic AND Rubber Products Co Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Polymer Patient Examination Glove and 2 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3028162329 |
| FEI number | 3028162329 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | 41 Shuangshan Road |
| Postal code | 255000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl | 2024 | 29 |
| Medical Glove, Specialty | Class 1 | Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl, Synthetic Nitrile Patient Exam Gloves, Powder Free, Tested for Use w/Chemotherapy Drug, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs | 2023 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl | 2024 | 32 |
| Polymer Patient Examination Glove | Class 1 | Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl, Synthetic Nitrile Patient Exam Gloves, Powder Free, Tested for Use w/Chemotherapy Drug, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs | 2023 | 83 |
Clearances
1 clearance names Xinwei (Shandong) Plastic AND Rubber Products Co Ltd. as applicant. 4 are held by other companies 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 |
|---|---|---|---|---|
| K121992 | 2012-10-16 | LZA | Traditional | This company |
| K232252 | 2023-11-28 | LZA | Traditional | Dehai (Shandong) Medical Gloves, Co., Ltd. |
| K170136 | 2017-08-25 | LZA | Traditional | Shandong Feiyang Professional Gloves Co., Ltd. |
| K161944 | 2016-11-21 | LZA | Traditional | Shandong Baisheng Medical Products Co., Ltd. |
| K123869 | 2013-02-28 | LZA | Traditional | Dehai (Shandong) Medical Gloves, Co., Ltd. |
Nearby Manufacturers
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.