Data / Medical devices / China / Hubei Haixin Protective Products Group Co.,Ltd
Hubei Haixin Protective Products Group Co.,Ltd: FDA-registered device maker in Songzi City Hubei, China, 3 510(k) clearances
Hubei Haixin Protective Products Group Co.,Ltd is registered with the FDA (registration 3004158259) in Songzi City Hubei, China. It lists 10 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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004158259
- Address
- Jinsong Avenue 8-8,Chengdong Industrial Zone, Songzi City Hubei, China, 434205
- Owner or operator
- Hubei Haixin Protective Products Group Co.,Ltd (9058446)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 24, 2006
- Registered through
- 2026
- Brand names listed
- AAMI 3 Fld Resist Surgical Isolation Gown, Bouffant Cap, CPE MATTRESS COVER,PP MATTRESS COVER, Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown, Earloop Procedure Mask, Face Shield, Isolation Gown, Non-surgical isolation gown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Contract manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | 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 Cover, Mattress (Medical Purposes)
- All makers of Suit, Surgical
- All makers of Cover, Shoe, Operating-Room
- All makers of Respirator, Surgical
- All makers of Gown, Examination
- All makers of Mask, Surgical
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.