Crown Name Disposable Hygiene Products Fty. Ltd.
Registered establishment in Wuhan, Hubei, China. 11 device types, 2 clearances.
Crown Name Disposable Hygiene Products Fty. Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 9 other device types. Its earliest product listing with the FDA dates from 2012.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010155681 |
| FEI number | 3010155681 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | No.508 Qi’an Avenue, Zhucheng Street, |
| Postal code | 431400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 2016 | 439 | |
| Bedding, Disposable, Medical | Class 1 | 2016 | 308 | |
| Cap, Surgical | Class 1 | 2017 | 178 | |
| Cover, Shoe, Operating-Room | Class 1 | 2014 | 176 | |
| Drape, Surgical, Exempt | Class 2 | 2020 | 107 | |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | 2020 | 182 | |
| Gown, Examination | Class 1 | 2016 | 109 | |
| Gown, Isolation, Surgical | Class 2 | Disposable Surgical Isolation Gown | 2022 | 21 |
| Mask, Surgical | Class 2 | 2020 | 125 | |
| Non-Surgical Gown | Class 1 | 2012 | 318 | |
| Suit, Surgical | Class 1 | 2016 | 74 |
Clearances
2 clearances name Crown Name Disposable Hygiene Products Fty. Ltd. as applicant. 2 are held by another company 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 |
|---|---|---|---|---|
| K212422 | 2022-04-29 | FYC | Traditional | This company |
| K203534 | 2021-07-21 | FXX | Traditional | This company |
| K070407 | 2007-03-26 | FXX | Traditional | Dukal LLC |
| K061864 | 2006-09-15 | FXX | Traditional | Dukal LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Employees | 2000+ |
| Factory area | 10,000m² |
| Main products | Disposable coveralls, Surgical gowns, Isolation gowns, Face masks, PPE nonwoven fabric |
| Certifications | CE, FDA, Medical equipment production license, ISO 9001, ISO 13485, BSCI |
| Export markets | 50+ 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.