Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tactyl Technologies, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
1365 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955464 | TACTYLON POWDER FREE EXAMINATION GLOVE | Tactyl Technologies, Inc. | 1996-04-25 | 147 | 0 |
| K955419 | POWDER FREE TACTYLON SURGEONS GLOVE | Tactyl Technologies, Inc. | 1996-04-15 | 140 | 0 |
| K953583 | LUBRICATED CONDOM | Tactyl Technologies, Inc. | 1996-01-26 | 178 | 0 |
| K950185 | TACTYLON(TM) POWDER FREE SURGEONS GLOVE | Tactyl Technologies, Inc. | 1995-04-13 | 86 | 0 |
| K911431 | TACTYLON(TM) CONDOM | Tactyl Technologies, Inc. | 1994-12-27 | 1365 | 0 |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Tactyl Technologies, Inc. | 1990-11-21 | 8 | 0 |
| K902831 | TACTYLON TM SURGICAL GLOVE | Tactyl Technologies, Inc. | 1990-07-10 | 12 | 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