# Shinemound Enterprise, Inc.

- Location (FDA's records): North Billerica, MA
- FDA decisions: 8 (1997–2005): 8 510(k) clearances
- Product codes: LYZ (6), LYY (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K051913: Powdered Latex Patient Examination Gloves (Sep 30, 2005)
- K994248: Sensi-Pro, Disposable Pre-Powdered Synthetic Vinyl Patient Examination Gloves with Beige Pigment Additives (Jan 28, 2000)
- K994258: Sensi-Pro Disposable Powder Free Synthetic Vinyl Patient Examination Gloves with Beige Pigment Additives (Jan 20, 2000)
- K993240: Sensi-Pro Disposable Powder Free Vinyl Synthetic Examination Gloves with White Pigment Additives (Oct 27, 1999)
- K993231: Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves with White Pigment Additives (Oct 27, 1999)
- K971360: Syntex (Dec 22, 1997)
- K972104: Lightly Powdered Vinyl Synthetic Examination Gloves (Aug 15, 1997)
- K970625: Poly-Med (Mar 27, 1997)

Source page: https://510kreport.com/company/shinemound-enterprise