Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Basic Medical Technology, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
167 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | 2026-04-07 | 22 | 0 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 | 119 | 0 |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | 2025-08-28 | 20 | 0 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemothe | Basic Medical Technology, Inc. | 2025-08-27 | 84 | 0 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Che | Basic Medical Technology, Inc. | 2025-07-09 | 167 | 0 |
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and te | Basic Medical Technology, Inc. | 2025-05-22 | 80 | 0 |
| K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemothe | Basic Medical Technology, Inc. | 2025-02-18 | 70 | 0 |
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemothe | Basic Medical Technology, Inc. | 2025-01-31 | 86 | 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