Data / Medical devices / Vietnam / Ever Global (vietnam) Enterprise Corporation
Ever Global (vietnam) Enterprise Corporation: FDA-registered device maker in An Phuoc Village Dong Nai, Vietnam, 7 510(k) clearances
Ever Global (vietnam) Enterprise Corporation is registered with the FDA (registration 3005024009) in An Phuoc Village Dong Nai, Vietnam. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 21, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005024009
- Address
- Route 1, Long Thanh Industrial Zone, An Phuoc Village Dong Nai, Vietnam, 76210
- Owner or operator
- Ever Global (Vietnam) Enterprise Corporation (10053933)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 17, 2017
- Registered through
- 2026
- Brand names listed
- Disposable Nitrile Examination Glove, Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, 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 | 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 |
|---|---|---|---|---|---|---|
| August 21, 2025 | K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation | accessdata.fda.gov |
| February 6, 2025 | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation | accessdata.fda.gov |
| February 6, 2023 | K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | LYZ | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation | accessdata.fda.gov |
| June 4, 2020 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | LZC | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp | accessdata.fda.gov |
| September 6, 2019 | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation | accessdata.fda.gov |
| June 11, 2018 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp | accessdata.fda.gov |
| May 16, 2017 | K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | LYZ | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
Updated August 21, 2025. 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.