Data / Medical devices / China / Hebei Handform Medical Products Co.,ltd.
Hebei Handform Medical Products Co.,ltd.: FDA-registered device maker in Xingtai Hebei, China, 4 510(k) clearances
Hebei Handform Medical Products Co.,ltd. is registered with the FDA (registration 3008388240) in Xingtai Hebei, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 24, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008388240
- Address
- Julu County industrial park, Xingtai Hebei, China, 055250
- Owner or operator
- Hebei Handform Medical Products Co.,Ltd. (10032406)
- Roles
- Manufacturer
- First device listed
- May 11, 2010
- Registered through
- 2026
- Brand names listed
- Clear Vinyl Examination Gloves Mediglove Brand, Vinyl examination gloves yellow, Vinyl patient examination glove, White Vinyl Exam Gloves Powder-free, Yellow Stretch Vinyl Examination Gloves Mediglove Brand
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | 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 |
|---|---|---|---|---|---|---|
| August 24, 2010 | K101358 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Hebei Handform Plastic Products Co., Ltd. | accessdata.fda.gov |
| June 17, 2010 | K101362 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) | LYZ | Substantially Equivalent | Hebei Handform Plastic Products Co., Ltd. | accessdata.fda.gov |
| February 9, 2009 | K082690 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Hebei Handform Plastic Products Co., Ltd. | accessdata.fda.gov |
| February 4, 2009 | K082691 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Hebei Handform Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 24, 2010. 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.