Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Supertex Industrial, S.A. DE C.V. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971102 | AMBIDERM | Supertex Industrial, S.A. DE C.V. | 1997-08-29 | 156 | 0 |
| K963866 | AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN) | Supertex Industrial, S.A. DE C.V. | 1997-02-10 | 210 | 0 |
| K962737 | AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN) | Supertex Industrial, S.A. DE C.V. | 1997-02-07 | 207 | 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