Rich Mountain Medical Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Rich Mountain Medical Products, Inc.” (first 2008, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 70 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Rich Mountain Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120190 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR | LYZ | 2012-04-02 | 70 |
| K082448 | DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED | LYZ | 2008-12-10 | 107 |
| K082447 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE | LYZ | 2008-10-14 | 50 |
| K082444 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | LYZ | 2008-09-30 | 36 |
| K082443 | DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE | LYZ | 2008-09-26 | 32 |
| K081539 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR | LYZ | 2008-09-26 | 116 |
| K081535 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | LYZ | 2008-08-14 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Rich Mountain Medical Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rich Mountain Medical Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Rich Mountain Medical Products, Inc.” (first 2008, latest 2012), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rich Mountain Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rich Mountain Medical Products, Inc. is 70 days.
Which FDA product codes appear under Rich Mountain Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 7).
Next steps
- See all 7 Rich Mountain Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Rich Mountain Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.