Data / Medical devices / China / Yue Kang Anhui Medical Products Co.,ltd
Yue Kang Anhui Medical Products Co.,ltd: FDA-registered device maker in huaibei Anhui, China, 2 510(k) clearances
Yue Kang Anhui Medical Products Co.,ltd is registered with the FDA (registration 3030682048) in huaibei Anhui, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030682048
- Address
- 375 Yuejin Road, huaibei Anhui, China, 235000
- Owner or operator
- Yue Kang Anhui Medical Products Co.,ltd (10090264)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 6, 2024
- Registered through
- 2026
- Brand names listed
- Nitrile examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy, Vinyl examination glove, disposable Nitrile examination glove, disposable Vinyl examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 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 |
|---|---|---|---|---|---|---|
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | accessdata.fda.gov |
| November 22, 2010 | K102444 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Yingbo Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Vinyl Patient Examination Glove
Updated October 16, 2012. 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.