Ug Global Resources Sdn. Bhd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ug Global Resources Sdn. Bhd.” (first 2012, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 313 days. Since 2017 the median was 297 days, against 114 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 |
|---|---|---|
| 2012 | 2 | 360 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 305 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 263 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ug Global Resources Sdn. Bhd. took a median 297 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Ug Global Resources Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232319 | Black Pearl Nitrile Examination Glove | LZA | 2024-04-22 | 263 |
| K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | LZA | 2017-07-18 | 313 |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | LYY | 2017-05-11 | 297 |
| K111718 | LANO-E | LZA | 2012-06-08 | 354 |
| K111604 | LANO-E | LYY | 2012-06-08 | 366 |
Recalls
openFDA lists no recalls under a recalling firm named Ug Global Resources Sdn. Bhd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ug Global Resources Sdn. Bhd.?
FDA lists 5 510(k) clearances under the applicant name “Ug Global Resources Sdn. Bhd.” (first 2012, latest 2024), across 2 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 Ug Global Resources Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ug Global Resources Sdn. Bhd. is 313 days. Since 2017: 297 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ug Global Resources Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 5 Ug Global Resources Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Ug Global Resources Sdn. Bhd.'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.