Ever Global (Vietnam) Enterprise Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ever Global (Vietnam) Enterprise Corporation” (first 2017, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 182 days. Since 2017 the median was 182 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 78 |
| 2018 | 1 | 392 |
| 2019 | 1 | 199 |
| 2020 | 1 | 167 |
| 2021 | 0 | — |
| 2022 | 1 | 198 |
| 2023 | 1 | 216 |
| 2024 | 0 | — |
| 2025 | 2 | 36 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ever Global (Vietnam) Enterprise Corporation took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| LYZ | Vinyl Patient Examination Glove | 3 | 3 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Ever Global (Vietnam) Enterprise Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2025-08-21 | 34 |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | LZA | 2025-02-06 | 38 |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | LYZ | 2023-02-06 | 216 |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | LYZ | 2022-10-19 | 198 |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | LZC | 2020-06-04 | 167 |
| 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 | 2019-09-06 | 199 |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | LZA | 2018-06-11 | 392 |
| K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | LYZ | 2017-05-16 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Ever Global (Vietnam) Enterprise Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ever Fortune.Ai, Co., Ltd. (15 510(k)s)
- Ever Light Plastic Products Co., Ltd. (11 510(k)s)
- Ever Growth (Vietnam) Co. , Ltd. (4 510(k)s)
- Ever Global Enterprise Corporation (2 510(k)s)
- Ever Prosperous Instrument, Inc. (2 510(k)s)
- Ever Surplus (Usa), Inc. (2 510(k)s)
- Ever Glory Intl., Inc. (1 510(k)s)
- Ever Great International , Ltd. (1 510(k)s)
- Ever Growing Ent. Co., Ltd. (1 510(k)s)
- Ever Growth (Vietnam) Corporation Limited (1 510(k)s)
- Ever Prime Enterprises , Ltd. (1 510(k)s)
- Ever Scientific (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ever Global (Vietnam) Enterprise Corporation?
FDA lists 8 510(k) clearances under the applicant name “Ever Global (Vietnam) Enterprise Corporation” (first 2017, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ever Global (Vietnam) Enterprise Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ever Global (Vietnam) Enterprise Corporation is 182 days. Since 2017: 182 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ever Global (Vietnam) Enterprise Corporation?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 4); LYZ (Vinyl Patient Examination Glove, 3); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 8 Ever Global (Vietnam) Enterprise Corporation clearances with predicates and recalls
- Run predicate analysis for product code LZA, Ever Global (Vietnam) Enterprise Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.