Data / Medical devices / China / Lianyungang Bronson Non-woven Products Co., Ltd.
Lianyungang Bronson Non-woven Products Co., Ltd.: FDA-registered device maker in LIANYUNGANG Jiangsu, China, 2 510(k) clearances
Lianyungang Bronson Non-woven Products Co., Ltd. is registered with the FDA (registration 3006400329) in LIANYUNGANG Jiangsu, China. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006400329
- Address
- No. 1069 Jingdu Road DONGHAI DEVELOPMENT ZONE, LIANYUNGANG Jiangsu, China, 222300
- Owner or operator
- LYG BRONSON NON-WOVEN PRODUCTS CO. LTD. (9096885)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 22, 2007
- Registered through
- 2026
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 | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| December 11, 2018 | K181174 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| November 12, 2009 | K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Non-Surgical Gown
- All makers of Fiber, Medical, Absorbent
- All makers of Gown, Examination
- All makers of Gown, Surgical
- All makers of Cap, Surgical
Updated December 11, 2018. 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.