Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shinemound Enterprise, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
255 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051913 | POWDERED LATEX PATIENT EXAMINATION GLOVES | Shinemound Enterprise, Inc. | 2005-09-30 | 77 | 0 |
| K994248 | SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT E | Shinemound Enterprise, Inc. | 2000-01-28 | 43 | 0 |
| K994258 | SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXA | Shinemound Enterprise, Inc. | 2000-01-20 | 34 | 0 |
| K993240 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION | Shinemound Enterprise, Inc. | 1999-10-27 | 30 | 0 |
| K993231 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GL | Shinemound Enterprise, Inc. | 1999-10-27 | 30 | 0 |
| K971360 | SYNTEX | Shinemound Enterprise, Inc. | 1997-12-22 | 255 | 0 |
| K972104 | LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES | Shinemound Enterprise, Inc. | 1997-08-15 | 72 | 0 |
| K970625 | POLY-MED | Shinemound Enterprise, Inc. | 1997-03-27 | 36 | 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