Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtexx Manufacturing Sdn. 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) |
|---|---|---|---|---|---|
| K120963 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Medtexx Manufacturing Sdn. Bhd. | 2012-06-29 | 91 | 0 |
| K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | Medtexx Manufacturing Sdn. Bhd. | 2007-10-04 | 99 | 0 |
| K070821 | POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LA | Medtexx Manufacturing Sdn. Bhd. | 2007-05-10 | 45 | 0 |
| K070072 | NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXA | Medtexx Manufacturing Sdn. Bhd. | 2007-03-15 | 66 | 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