Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LZB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052387 | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | Arthrex, Inc. | 2005-11-29 | 90 | 0 |
| K992539 | PERCUGUARD | Digit-Pro | 2000-02-18 | 203 | 0 |
| K980827 | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | Tucker & Associates | 1998-05-04 | 62 | 0 |
| K912042 | BETHEL PLUS MULTIPLE NAMES | Bethel Latex Products, Inc. | 1991-07-02 | 55 | 0 |
| K903073 | LATEX FINGER COTS | Dongkuk Trading Co., Ltd. | 1990-09-12 | 62 | 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