Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hartalega Sdb. Bhd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162924 | Nitrile Powder Free Examination Gloves Tested for Use with C | Hartalega Sdb. Bhd. | 2017-01-24 | 98 | 0 |
| K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein | Hartalega Sdb. Bhd. | 2016-12-20 | 260 | 0 |
| K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal | Hartalega Sdb. Bhd. | 2014-12-18 | 80 | 0 |
| K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAI | Hartalega Sdb. Bhd. | 2014-11-25 | 102 | 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