Data / Medical devices / China / Premier Medical Gloves Factory
Premier Medical Gloves Factory: FDA-registered device maker in Weifang Shandong, China, 3 510(k) clearances
Premier Medical Gloves Factory is registered with the FDA (registration 3009118264) in Weifang Shandong, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 4, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009118264
- Address
- No. 8-2, Xingan Rd.,Dongcheng, Linqu, Weifang Shandong, China, 262600
- Owner or operator
- PREMIER MEDICAL GLOVES FACTORY (10037441)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- July 13, 2011
- 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, Specification developer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| 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 |
| June 16, 2011 | K111297 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) | LYZ | Substantially Equivalent | Premier Medical Gloves Factory | accessdata.fda.gov |
Compare with other makers
- 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 Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Vinyl Patient Examination Glove
Updated December 4, 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.