FDA Registration
Active
🇨🇳 China
XIANTAO ZHIBO NONWOVEN PRODUCTS CO.,LTD
Reg #: 3013580507
·
FEI: 3013580507
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- XIANTAO ZHIBO NONWOVEN PRODUCTS CO.,LTD
- Registration Number
- 3013580507
- FEI Number
- 3013580507
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8, Hefeng industrial zone ,, Pengchang Town
- City
- Xiantao City Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231510
Owner / Operator
- Firm Name
- Xiantao Zhibo Nonwoven Products Co.,Ltd
- Operator Number
- 10053753
- Address
- No.8, Hefeng industrial zone ,, Pengchang Town
- City
- Xiantao City
- State
- Hubei
- Postal Code
- 430000
- Country
- CN
- Correspondent
- Fen Peng
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2018-06-24 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2018-06-24 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2023-09-06 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-06-24 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2019-02-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2017-01-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2017-01-07 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2024-09-10 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2017-01-07 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2017-01-07 |
Proprietary Names
Shoe cover, Boots, Sleeves
Surgical Gown
Surgical Gown, Reinforced Surgical Gown
Isolation Gown, Protective clothing, coverall, medical, CPE gown, Scrub Suit
Mask, Surgical
Bed sheet, Pillow Cover
Gloves, Apron, Apparel
Disposable Scrub
Disposable Medical Face Mask
Cap
Mask
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device