FDA applicant

Shinemound Enterprise, Inc.

North Billerica, MA8 decisions1997–20050 recalls

FDA records 8 decisions for Shinemound Enterprise, Inc. (North Billerica, MA) from 1997 to 2005: 8 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LYY (Latex Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Shinemound Enterprise, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shinemound Enterprise, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shinemound Enterprise, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Shinemound Enterprise, Inc.

Which product codes does it file in?

What has FDA decided for it lately?