Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Latexx Partners Bhd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
67 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011791 | POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR | Latexx Partners Bhd. | 2001-08-01 | 54 | 0 |
| K011792 | NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT | Latexx Partners Bhd. | 2001-08-01 | 54 | 0 |
| K992924 | QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOV | Latexx Partners Bhd. | 1999-11-05 | 67 | 0 |
| K992671 | QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES | Latexx Partners Bhd. | 1999-09-24 | 45 | 0 |
| K991462 | QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED | Latexx Partners Bhd. | 1999-05-28 | 31 | 0 |
| K981767 | QTEXX POWDERFREE LATEX EXAMINATION GLOVES | Latexx Partners Bhd. | 1998-06-11 | 23 | 0 |
| K981159 | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES | Latexx Partners Bhd. | 1998-06-01 | 62 | 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