Shinemound Enterprise, Inc.
N Billerica, MA, US
SHINEMOUND ENTERPRISE, INC. appears in FDA device records in N Billerica, MA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Shinemound Enterprise, Inc. between 1997 and 2005. The busiest year on record is 1997, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1999 | 2 |
| 2000 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051913 | POWDERED LATEX PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K994248 | SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES | LYZ | Substantially Equivalent | |
| K994258 | SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES | LYZ | Substantially Equivalent | |
| K993240 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES | LYZ | Substantially Equivalent | |
| K993231 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES | LYZ | Substantially Equivalent | |
| K971360 | SYNTEX | LYZ | Substantially Equivalent | |
| K972104 | LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES | LYZ | Substantially Equivalent | |
| K970625 | POLY-MED | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221921 | 1221921 | SHINEMOUND ENTERPRISE, INC. | 19 Sterling Rd Ste 6A, N Billerica, MA 01862 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain