Data / Medical devices / China / Anhui Huaihai Medical Gloves Co., Ltd
Anhui Huaihai Medical Gloves Co., Ltd: FDA-registered device maker in Huaibei Anhui, China, 4 510(k) clearances
Anhui Huaihai Medical Gloves Co., Ltd is registered with the FDA (registration 3029952428) in Huaibei Anhui, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated February 5, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3029952428
- Address
- 150 meters east of 303 Suixi County, Huaibei City, Anhui Province,China, Huaibei Anhui, China, 235100
- Owner or operator
- Anhui Huaihai Medical Gloves Co., Ltd (10088760)
- Roles
- Manufacturer
- First device listed
- October 9, 2023
- Registered through
- 2026
- Brand names listed
- Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Patient Vinyl Examination Gloves, Powder Free, Non-Sterile,Yellow Color
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 |
|---|---|---|---|---|---|---|
| February 5, 2016 | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue | LYZ | Substantially Equivalent | Zibo Huiying Medical Products, Co. , Ltd. | accessdata.fda.gov |
| January 7, 2014 | K131832 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Binxiang Medical Products Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K112266 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Shandong Zhiyuan Medical Products Co., Ltd. | accessdata.fda.gov |
| July 15, 2011 | K110857 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Shandong Zhanpeng Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 5, 2016. 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.