Data / Medical devices / China / Guilin HBM Health Protections, Inc.
Guilin HBM Health Protections, Inc.: FDA-registered device maker in Guilin Guangxi, China, 3 510(k) clearances
Guilin HBM Health Protections, Inc. is registered with the FDA (registration 3018299689) in Guilin Guangxi, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 13, 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
- 3018299689
- Address
- No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin Guangxi, China, 541805
- Owner or operator
- Guilin HBM Health Protections, Inc. (10080538)
- Roles
- Manufacturer
- First device listed
- February 8, 2021
- Registered through
- 2026
- Brand names listed
- Cardinal Health Protegrity Surgical Gloves, MEDIZERO LATEX SURGICAL GLOVE, MEDIZERO LATEX SURGICAL GLOVES, MEDIZERO POLYISOPRENE SURGICAL GLOVE, MEDIZERO UNDERGLOVE SURGICAL GLOVES, RADIATION PROTECTION SURGICAL GLOVES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiographic Protective Glove | IWP | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 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 13, 2022 | K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | KGO | Substantially Equivalent | Guilin Hbm Health Protections, Inc. | accessdata.fda.gov |
| February 1, 2021 | K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | KGO | Substantially Equivalent | Guilin Hbm Health Protections, Inc. | accessdata.fda.gov |
| May 11, 2005 | K050071 | MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE | KGO | Substantially Equivalent | H.B.M. USA Co.,Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 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.