Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alatech Healthcare, LLC · 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) |
|---|---|---|---|---|---|
| K083761 | ALATECH POWDER FREE LATEX EXAMINATION GLOVE | Alatech Healthcare, LLC | 2009-07-22 | 216 | 0 |
| K082529 | ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM | Alatech Healthcare, LLC | 2009-05-01 | 241 | 0 |
| K080606 | ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE | Alatech Healthcare, LLC | 2008-08-07 | 156 | 0 |
| K993887 | ALATECH LATEX CONDOM | Alatech Healthcare, LLC | 1999-12-20 | 34 | 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