Data / Medical devices / China / Shandong Hengya Packaging Printing Co.,ltd
Shandong Hengya Packaging Printing Co.,ltd: FDA-registered device maker in Weifang Shandong, China, 4 510(k) clearances
Shandong Hengya Packaging Printing Co.,ltd is registered with the FDA (registration 3015412466) in Weifang Shandong, China. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015412466
- Address
- Hetou village, Yingqiu town, Changle county, Weifang Shandong, China, 262416
- Owner or operator
- Shandong Hengya Packaging Printing Co.,Ltd (10060268)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- April 17, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | LZA | Substantially Equivalent | Zibo Kaiyue Mould Technology Co., Ltd. | accessdata.fda.gov |
| December 4, 2022 | K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Zibo Lanhua Medical Packaging Material Co., Ltd. | accessdata.fda.gov |
| April 12, 2019 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | Substantially Equivalent | Shandong Hengya Packaging Printing Co.,Ltd | accessdata.fda.gov |
| May 10, 2011 | K110314 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) | LYZ | Substantially Equivalent | True Glove Factory | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
Updated December 15, 2023. 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.