Shinemound Enterprise, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shinemound Enterprise, Inc.” (first 1997, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 | 0 | — |
| 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 | 6 | 6 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (8)
Most recent Shinemound Enterprise, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051913 | POWDERED LATEX PATIENT EXAMINATION GLOVES | LYY | 2005-09-30 | 77 |
| K994248 | SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES | LYZ | 2000-01-28 | 43 |
| K994258 | SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES | LYZ | 2000-01-20 | 34 |
| K993240 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES | LYZ | 1999-10-27 | 30 |
| K993231 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES | LYZ | 1999-10-27 | 30 |
| K971360 | SYNTEX | LYZ | 1997-12-22 | 255 |
| K972104 | LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES | LYZ | 1997-08-15 | 72 |
| K970625 | POLY-MED | LYY | 1997-03-27 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Shinemound Enterprise, 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 Shinemound Enterprise, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Shinemound Enterprise, Inc.” (first 1997, latest 2005), across 2 product codes 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 Shinemound Enterprise, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shinemound Enterprise, Inc. is 40 days.
Which FDA product codes appear under Shinemound Enterprise, Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 8 Shinemound Enterprise, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Shinemound Enterprise, 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.