Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ug Global Resources Sdn. Bhd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
313 daysmedian FDA review time
366 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232319 | Black Pearl Nitrile Examination Glove | Ug Global Resources Sdn. Bhd. | 2024-04-22 | 263 | 0 |
| K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | Ug Global Resources Sdn. Bhd. | 2017-07-18 | 313 | 0 |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | Ug Global Resources Sdn. Bhd. | 2017-05-11 | 297 | 0 |
| K111604 | LANO-E | Ug Global Resources Sdn. Bhd. | 2012-06-08 | 366 | 0 |
| K111718 | LANO-E | Ug Global Resources Sdn. Bhd. | 2012-06-08 | 354 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda