FDA Registration
Active
🇨🇳 China
HE CHUANG PLASTIC & RUBBER CO., LTD
Reg #: 3015335977
·
FEI: 3015335977
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- HE CHUANG PLASTIC & RUBBER CO., LTD
- Registration Number
- 3015335977
- FEI Number
- 3015335977
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 2, No. 21 Qingtian Road, Qilu Chemical Industrial Park
- City
- Zibo Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222815
Owner / Operator
- Firm Name
- He Chuang Plastic & Rubber Co., Ltd
- Operator Number
- 10060105
- Address
- Lot 2, No. 21 Qingtian Road, Qilu Chemical Industrial Park
- City
- Zibo
- State
- Shandong
- Postal Code
- 255414
- Country
- CN
- Correspondent
- Coco Wang
US Agent
- Business Name
- Omni International Corp
- Contact Name
- Ken Li
- Address
- 35 Constitution Dr Ste 1D
- City
- Bedford
- State
- NH
- ZIP
- 03110
- Country
- US
- [email protected]
- Phone
- 603 4711499
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2022-12-28 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-12-28 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-12-28 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-12-28 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device