Data / Medical devices / Vietnam / Ever Global (vietnam) Enterprise Corporation
Ever Global (vietnam) Enterprise Corporation: FDA-registered device maker in Long Khanh City Dong Nai, Vietnam, 4 510(k) clearances
Ever Global (vietnam) Enterprise Corporation is registered with the FDA (registration 3013514660) in Long Khanh City Dong Nai, Vietnam. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 7, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013514660
- Address
- Long Khanh Industrial Zone Binh Loc Commune, Long Khanh City Dong Nai, Vietnam, 76461
- Owner or operator
- EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION (10054085)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 31, 2018
- Registered through
- 2026
- Brand names listed
- Disposable Powder Free Nitrile Examination Glove, Black Color, Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrat, Disposable Powder Free Nitrile Examination Glove, Pink Color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color
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, 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 | 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 |
|---|---|---|---|---|---|---|
| January 7, 2020 | K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | LZA | Substantially Equivalent | Ever Growth (Vietnam) Co. , Ltd. | accessdata.fda.gov |
| December 23, 2019 | K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color | LZA | Substantially Equivalent | Ever Growth (Vietnam) Co. , Ltd. | accessdata.fda.gov |
| December 23, 2019 | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Ever Growth (Vietnam) Co. , Ltd. | accessdata.fda.gov |
| December 29, 2017 | K172357 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | LYZ | Substantially Equivalent | Ever Growth (Vietnam) Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
Updated January 7, 2020. 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.