Data / Medical devices / China / Crown Name Disposable Hygiene Products Fty. Ltd.
Crown Name Disposable Hygiene Products Fty. Ltd.: FDA-registered device maker in Wuhan Hubei, China, 4 510(k) clearances
Crown Name Disposable Hygiene Products Fty. Ltd. is registered with the FDA (registration 3010155681) in Wuhan Hubei, China. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010155681
- Address
- No.508 Qi'an Avenue, Zhucheng Street, Xinzhou District, Wuhan Hubei, China, 431400
- Owner or operator
- Crown Name Disposable Hygiene Products Fty. Ltd. (10042236)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 2, 2012
- Registered through
- 2026
- Brand names listed
- Disposable Surgical Isolation Gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2022 | K212422 | Disposable Surgical Isolation Gown | FYC | Substantially Equivalent | Crown Name Disposable Hygiene Products Fty., Ltd. | accessdata.fda.gov |
| July 21, 2021 | K203534 | Surgical face mask (Model: Flat Ear Loop/CN102) | FXX | Substantially Equivalent | Crown Name Disposable Hygiene Products Fty., Ltd. | accessdata.fda.gov |
| March 26, 2007 | K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | FXX | Substantially Equivalent | Dukal Corp. | accessdata.fda.gov |
| September 15, 2006 | K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | FXX | Substantially Equivalent | Dukal Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Cap, Surgical
- All makers of Bedding, Disposable, Medical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Gown, Examination
- All makers of Suit, Surgical
Updated April 29, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.