HE Chuang Plastic & Rubber Co., Ltd.
Registered establishment in Zibo, Shandong, China. 4 device types, 1 clearance.
HE Chuang Plastic & Rubber Co., Ltd. is a specification developer 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 2019.
Registration
| Registered name | HE CHUANG PLASTIC & RUBBER CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015335977 |
| FEI number | 3015335977 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 美国海关记录适用于此业务及所有其他工厂 |
|---|---|
| Source | ImportGenius customs records |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | Lot 2, No. 21 Qingtian Road |
| Postal code | 255414 |
| 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 | 2019 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2022 | 32 |
| Polymer Patient Examination Glove | Class 1 | 2019 | 83 |
Clearances
1 clearance names HE Chuang Plastic & Rubber Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K182554 | 2019-03-22 | LZA | Traditional | This company |
| K222815 | 2022-12-04 | LZA | Traditional | Zibo Lanhua Medical Packaging Material Co., Ltd. |
| K220228 | 2022-03-18 | LZA | Traditional | Shandong Blue Sail Health Technology 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.