Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Rich Mountain Medical Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
116 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120190 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR | Rich Mountain Medical Products, Inc. | 2012-04-02 | 70 | 0 |
| K082448 | DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED | Rich Mountain Medical Products, Inc. | 2008-12-10 | 107 | 0 |
| K082447 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE | Rich Mountain Medical Products, Inc. | 2008-10-14 | 50 | 0 |
| K082444 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | Rich Mountain Medical Products, Inc. | 2008-09-30 | 36 | 0 |
| K081539 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE | Rich Mountain Medical Products, Inc. | 2008-09-26 | 116 | 0 |
| K082443 | DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Rich Mountain Medical Products, Inc. | 2008-09-26 | 32 | 0 |
| K081535 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE CO | Rich Mountain Medical Products, Inc. | 2008-08-14 | 73 | 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