Data / Medical devices / China / Jingzhou Haixin Green Cross Medical Products Co.,ltd
Jingzhou Haixin Green Cross Medical Products Co.,ltd: FDA-registered device maker in Jingzhou Hubei, China, 3 510(k) clearances
Jingzhou Haixin Green Cross Medical Products Co.,ltd is registered with the FDA (registration 3017597597) in Jingzhou Hubei, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017597597
- Address
- Yongxing North Road No.2, Jingzhou Hubei, China, 434200
- Owner or operator
- Jingzhou Haixin Green Cross Medical Products Co.,Ltd (10078959)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 12, 2020
- Registered through
- 2026
- Brand names listed
- Bouffant Cap, Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown; Non-Surgical Isolation Gown, Earloop Procedure Mask, Face Shield, GOWN, ISOLATION, SURGICAL, Isolation Gown, Room, Suit Surgical and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 26, 2022 | K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | accessdata.fda.gov |
| February 15, 2018 | K171535 | SURGICAL ISOLATION GOWN | FYC | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Mask, Surgical
- All makers of Cap, Surgical
- All makers of Gown, Isolation, Surgical
- All makers of Gown, Examination
- All makers of Non-Surgical Gown
Updated September 26, 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.