Guangzhou Fuzelong Hygiene Material Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 17 device types, 3 products catalogued, 2 clearances.
Guangzhou Fuzelong Hygiene Material Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Basin, Emesis and 15 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008559312 |
| FEI number | 3008559312 |
| DUNS | 546983737 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州福泽龙卫生材料有限责任公司 |
|---|---|
| Unified social credit code | 914401847837984924 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | #12, Guancun Road |
| Postal code | 510900 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | puyuan, puyuan face shield, IMPERTEC INDUSTRIES LTD Face Shield /Hood, surgical gown with hood | 2021 | 439 |
| Bag, Ice | Class 1 | Pu Yuan | 2024 | 86 |
| Basin, Emesis | Class 1 | Emesis Basin | 2018 | 65 |
| Bedding, Disposable, Medical | Class 1 | pillow cover, bedsheet, tissue polly | 2021 | 308 |
| Cap, Surgical | Class 1 | Puyuan, Surgical hood | 2010 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Puyuan | 2010 | 176 |
| Cup, Prophylaxis | Class 1 | Puyuan | 2018 | 49 |
| Drape, Adhesive, Aerosol | Class 1 | drap | 2021 | 12 |
| Drape, Surgical, Exempt | Class 2 | puyuan SDKP-0406 Laparoscopic abdominal surgery drap 254*193*315cm, puyuan surgical packs | 2021 | 107 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | gauze | 2024 | 266 |
| Gown, Examination | Class 1 | Puyuan | 2010 | 109 |
| Gown, Surgical | Class 2 | Surgical Gown | 2023 | 68 |
| Mask, Scavenging | Class 1 | Puyuan | 2010 | 158 |
| Mask, Surgical | Class 2 | Medline Surgical Face Mask and Medline Procedural Face Mask, Disposable Medical Mask, Puyuan | 2015 | 125 |
| Non-Surgical Gown | Class 1 | scrub, scrub suit, apron, level 2 surgical gown, lab coat, operation room gown and 4 more | 2021 | 318 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | peel away lens | 2022 | 384 |
| Tray, Surgical | Class 1 | Puyuan | 2018 | 36 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222545 | 2023-05-19 | FXX | Traditional | This company |
| K222403 | 2023-01-26 | FYA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Factory area | 8700 m² |
| Main products | Surgical gowns, Surgical drapes, Surgical packs, Non-woven products |
| Certifications | CE, FDA, Chinese medical device registration |
| Export markets | 38+ countries |
| OEM and ODM | Offered |
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.